Clinical Trials Unit
Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit.
The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications. The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments. New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies.
Skin Aging Studies
We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.
Nonmelanoma Skin Cancer
Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.
Acne Rosecea
This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.
Contact
For more information, please email dermtrials@stanford.edu
Featured Clinical Trials
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA).
The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Oral Insulin
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Have a proband with Type 1 diabetes mellitus (T1DM). A proband is an individual
diagnosed with diabetes before age 40 and started on insulin therapy within 1-year of
diagnosis. Probands considered to have type 1 diabetes by their physician who do not
meet this definition will be referred to the TrialNet Eligibility Committee.
2. If the proband is a parent, sibling or a child, the study participant must be 3 -45
years of age. If the proband is a second or third degree relative (i.e. niece, nephew,
aunt, uncle, grandparent, cousin, or half-sibling), the study participant must be 3-20
years of age.
3. Willing to sign Informed Consent Form.
4. Oral glucose tolerance test (OGTT) performed within 7 weeks prior to randomization in
which:
- fasting plasma glucose < 110 mg/dL (6.1 mmol/l), and
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
5. mIAA confirmed positive within the previous six months.
6. Two samples with at least one autoantibody other than mIAA positive within the
previous six months.
Exclusion Criteria:
1. Does not satisfy the above inclusion criteria. Subjects with mIAA positive but no
other autoantibodies positive are not eligible for randomization.
2. Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary,
renal, hepatic, immune deficiency and/or disease that is likely to limit life
expectancy or lead to therapies such as immunosuppression during the time of the
study.
3. Prior participation in a trial for prevention of T1DM, e.g. nicotinamide, insulin,
immunosuppressive drugs.
4. History of treatment with insulin or oral hypoglycemic agent.
5. History of therapy with immunosuppressive drugs or glucocorticoids within the past two
years for a period of more than three months.
6. Ongoing use of medications known to influence glucose, i.e. sulfonylureas, growth
hormone, metformin, anticonvulsants, thiazide or potassium depleting diuretics, beta
adrenergic blockers, niacin. Subjects on such medications should be changed to a
suitable alternative, if available, and will become eligible one month after
medication is discontinued.
7. Pregnant or intends to become pregnant while on study or lactating.
8. Deemed unlikely or unable to comply with the protocol.
9. OGTT that reveals Diabetes, Impaired Glucose Tolerance (IGT), or Impaired Fasting
Glucose (IFG).
Diabetes is defined by:
- fasting plasma glucose ³ 126 mg/dL (7 mmol/l), OR
- 2 hour plasma glucose ³ 200 mg/dL (11.1 mmol/l)
IGT is defined by:
- fasting plasma glucose < 126 mg/dL (7 mmol/l), and
- 2 hour plasma glucose 140-199 mg/dL (7.8 - 11mmol/l),
IFG is defined by:
- fasting plasma glucose 110-125 mg/dL (6.1-6.9 mmol/l) AND
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
10. Subject has HLA DQA1*0102, DQB1*0602 haplotype.
Ages Eligible for Study
3 Years - 45 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alison Rigby
6504984450
I'm interested
Psoriasis Clinical Trials
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA).
The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Oral Insulin
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Have a proband with Type 1 diabetes mellitus (T1DM). A proband is an individual
diagnosed with diabetes before age 40 and started on insulin therapy within 1-year of
diagnosis. Probands considered to have type 1 diabetes by their physician who do not
meet this definition will be referred to the TrialNet Eligibility Committee.
2. If the proband is a parent, sibling or a child, the study participant must be 3 -45
years of age. If the proband is a second or third degree relative (i.e. niece, nephew,
aunt, uncle, grandparent, cousin, or half-sibling), the study participant must be 3-20
years of age.
3. Willing to sign Informed Consent Form.
4. Oral glucose tolerance test (OGTT) performed within 7 weeks prior to randomization in
which:
- fasting plasma glucose < 110 mg/dL (6.1 mmol/l), and
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
5. mIAA confirmed positive within the previous six months.
6. Two samples with at least one autoantibody other than mIAA positive within the
previous six months.
Exclusion Criteria:
1. Does not satisfy the above inclusion criteria. Subjects with mIAA positive but no
other autoantibodies positive are not eligible for randomization.
2. Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary,
renal, hepatic, immune deficiency and/or disease that is likely to limit life
expectancy or lead to therapies such as immunosuppression during the time of the
study.
3. Prior participation in a trial for prevention of T1DM, e.g. nicotinamide, insulin,
immunosuppressive drugs.
4. History of treatment with insulin or oral hypoglycemic agent.
5. History of therapy with immunosuppressive drugs or glucocorticoids within the past two
years for a period of more than three months.
6. Ongoing use of medications known to influence glucose, i.e. sulfonylureas, growth
hormone, metformin, anticonvulsants, thiazide or potassium depleting diuretics, beta
adrenergic blockers, niacin. Subjects on such medications should be changed to a
suitable alternative, if available, and will become eligible one month after
medication is discontinued.
7. Pregnant or intends to become pregnant while on study or lactating.
8. Deemed unlikely or unable to comply with the protocol.
9. OGTT that reveals Diabetes, Impaired Glucose Tolerance (IGT), or Impaired Fasting
Glucose (IFG).
Diabetes is defined by:
- fasting plasma glucose ³ 126 mg/dL (7 mmol/l), OR
- 2 hour plasma glucose ³ 200 mg/dL (11.1 mmol/l)
IGT is defined by:
- fasting plasma glucose < 126 mg/dL (7 mmol/l), and
- 2 hour plasma glucose 140-199 mg/dL (7.8 - 11mmol/l),
IFG is defined by:
- fasting plasma glucose 110-125 mg/dL (6.1-6.9 mmol/l) AND
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
10. Subject has HLA DQA1*0102, DQB1*0602 haplotype.
Ages Eligible for Study
3 Years - 45 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alison Rigby
6504984450
I'm interested
Dermatology Clinical Trials
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA).
The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Oral Insulin
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Have a proband with Type 1 diabetes mellitus (T1DM). A proband is an individual
diagnosed with diabetes before age 40 and started on insulin therapy within 1-year of
diagnosis. Probands considered to have type 1 diabetes by their physician who do not
meet this definition will be referred to the TrialNet Eligibility Committee.
2. If the proband is a parent, sibling or a child, the study participant must be 3 -45
years of age. If the proband is a second or third degree relative (i.e. niece, nephew,
aunt, uncle, grandparent, cousin, or half-sibling), the study participant must be 3-20
years of age.
3. Willing to sign Informed Consent Form.
4. Oral glucose tolerance test (OGTT) performed within 7 weeks prior to randomization in
which:
- fasting plasma glucose < 110 mg/dL (6.1 mmol/l), and
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
5. mIAA confirmed positive within the previous six months.
6. Two samples with at least one autoantibody other than mIAA positive within the
previous six months.
Exclusion Criteria:
1. Does not satisfy the above inclusion criteria. Subjects with mIAA positive but no
other autoantibodies positive are not eligible for randomization.
2. Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary,
renal, hepatic, immune deficiency and/or disease that is likely to limit life
expectancy or lead to therapies such as immunosuppression during the time of the
study.
3. Prior participation in a trial for prevention of T1DM, e.g. nicotinamide, insulin,
immunosuppressive drugs.
4. History of treatment with insulin or oral hypoglycemic agent.
5. History of therapy with immunosuppressive drugs or glucocorticoids within the past two
years for a period of more than three months.
6. Ongoing use of medications known to influence glucose, i.e. sulfonylureas, growth
hormone, metformin, anticonvulsants, thiazide or potassium depleting diuretics, beta
adrenergic blockers, niacin. Subjects on such medications should be changed to a
suitable alternative, if available, and will become eligible one month after
medication is discontinued.
7. Pregnant or intends to become pregnant while on study or lactating.
8. Deemed unlikely or unable to comply with the protocol.
9. OGTT that reveals Diabetes, Impaired Glucose Tolerance (IGT), or Impaired Fasting
Glucose (IFG).
Diabetes is defined by:
- fasting plasma glucose ³ 126 mg/dL (7 mmol/l), OR
- 2 hour plasma glucose ³ 200 mg/dL (11.1 mmol/l)
IGT is defined by:
- fasting plasma glucose < 126 mg/dL (7 mmol/l), and
- 2 hour plasma glucose 140-199 mg/dL (7.8 - 11mmol/l),
IFG is defined by:
- fasting plasma glucose 110-125 mg/dL (6.1-6.9 mmol/l) AND
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
10. Subject has HLA DQA1*0102, DQB1*0602 haplotype.
Ages Eligible for Study
3 Years - 45 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alison Rigby
6504984450
I'm interested
Pediatric Dermatology Clinical Trials
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA).
The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Oral Insulin
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Have a proband with Type 1 diabetes mellitus (T1DM). A proband is an individual
diagnosed with diabetes before age 40 and started on insulin therapy within 1-year of
diagnosis. Probands considered to have type 1 diabetes by their physician who do not
meet this definition will be referred to the TrialNet Eligibility Committee.
2. If the proband is a parent, sibling or a child, the study participant must be 3 -45
years of age. If the proband is a second or third degree relative (i.e. niece, nephew,
aunt, uncle, grandparent, cousin, or half-sibling), the study participant must be 3-20
years of age.
3. Willing to sign Informed Consent Form.
4. Oral glucose tolerance test (OGTT) performed within 7 weeks prior to randomization in
which:
- fasting plasma glucose < 110 mg/dL (6.1 mmol/l), and
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
5. mIAA confirmed positive within the previous six months.
6. Two samples with at least one autoantibody other than mIAA positive within the
previous six months.
Exclusion Criteria:
1. Does not satisfy the above inclusion criteria. Subjects with mIAA positive but no
other autoantibodies positive are not eligible for randomization.
2. Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary,
renal, hepatic, immune deficiency and/or disease that is likely to limit life
expectancy or lead to therapies such as immunosuppression during the time of the
study.
3. Prior participation in a trial for prevention of T1DM, e.g. nicotinamide, insulin,
immunosuppressive drugs.
4. History of treatment with insulin or oral hypoglycemic agent.
5. History of therapy with immunosuppressive drugs or glucocorticoids within the past two
years for a period of more than three months.
6. Ongoing use of medications known to influence glucose, i.e. sulfonylureas, growth
hormone, metformin, anticonvulsants, thiazide or potassium depleting diuretics, beta
adrenergic blockers, niacin. Subjects on such medications should be changed to a
suitable alternative, if available, and will become eligible one month after
medication is discontinued.
7. Pregnant or intends to become pregnant while on study or lactating.
8. Deemed unlikely or unable to comply with the protocol.
9. OGTT that reveals Diabetes, Impaired Glucose Tolerance (IGT), or Impaired Fasting
Glucose (IFG).
Diabetes is defined by:
- fasting plasma glucose ³ 126 mg/dL (7 mmol/l), OR
- 2 hour plasma glucose ³ 200 mg/dL (11.1 mmol/l)
IGT is defined by:
- fasting plasma glucose < 126 mg/dL (7 mmol/l), and
- 2 hour plasma glucose 140-199 mg/dL (7.8 - 11mmol/l),
IFG is defined by:
- fasting plasma glucose 110-125 mg/dL (6.1-6.9 mmol/l) AND
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
10. Subject has HLA DQA1*0102, DQB1*0602 haplotype.
Ages Eligible for Study
3 Years - 45 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alison Rigby
6504984450
I'm interested
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA).
The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Oral Insulin
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Have a proband with Type 1 diabetes mellitus (T1DM). A proband is an individual
diagnosed with diabetes before age 40 and started on insulin therapy within 1-year of
diagnosis. Probands considered to have type 1 diabetes by their physician who do not
meet this definition will be referred to the TrialNet Eligibility Committee.
2. If the proband is a parent, sibling or a child, the study participant must be 3 -45
years of age. If the proband is a second or third degree relative (i.e. niece, nephew,
aunt, uncle, grandparent, cousin, or half-sibling), the study participant must be 3-20
years of age.
3. Willing to sign Informed Consent Form.
4. Oral glucose tolerance test (OGTT) performed within 7 weeks prior to randomization in
which:
- fasting plasma glucose < 110 mg/dL (6.1 mmol/l), and
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
5. mIAA confirmed positive within the previous six months.
6. Two samples with at least one autoantibody other than mIAA positive within the
previous six months.
Exclusion Criteria:
1. Does not satisfy the above inclusion criteria. Subjects with mIAA positive but no
other autoantibodies positive are not eligible for randomization.
2. Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary,
renal, hepatic, immune deficiency and/or disease that is likely to limit life
expectancy or lead to therapies such as immunosuppression during the time of the
study.
3. Prior participation in a trial for prevention of T1DM, e.g. nicotinamide, insulin,
immunosuppressive drugs.
4. History of treatment with insulin or oral hypoglycemic agent.
5. History of therapy with immunosuppressive drugs or glucocorticoids within the past two
years for a period of more than three months.
6. Ongoing use of medications known to influence glucose, i.e. sulfonylureas, growth
hormone, metformin, anticonvulsants, thiazide or potassium depleting diuretics, beta
adrenergic blockers, niacin. Subjects on such medications should be changed to a
suitable alternative, if available, and will become eligible one month after
medication is discontinued.
7. Pregnant or intends to become pregnant while on study or lactating.
8. Deemed unlikely or unable to comply with the protocol.
9. OGTT that reveals Diabetes, Impaired Glucose Tolerance (IGT), or Impaired Fasting
Glucose (IFG).
Diabetes is defined by:
- fasting plasma glucose ³ 126 mg/dL (7 mmol/l), OR
- 2 hour plasma glucose ³ 200 mg/dL (11.1 mmol/l)
IGT is defined by:
- fasting plasma glucose < 126 mg/dL (7 mmol/l), and
- 2 hour plasma glucose 140-199 mg/dL (7.8 - 11mmol/l),
IFG is defined by:
- fasting plasma glucose 110-125 mg/dL (6.1-6.9 mmol/l) AND
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
10. Subject has HLA DQA1*0102, DQB1*0602 haplotype.
Ages Eligible for Study
3 Years - 45 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alison Rigby
6504984450
I'm interested
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA).
The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Oral Insulin
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Have a proband with Type 1 diabetes mellitus (T1DM). A proband is an individual
diagnosed with diabetes before age 40 and started on insulin therapy within 1-year of
diagnosis. Probands considered to have type 1 diabetes by their physician who do not
meet this definition will be referred to the TrialNet Eligibility Committee.
2. If the proband is a parent, sibling or a child, the study participant must be 3 -45
years of age. If the proband is a second or third degree relative (i.e. niece, nephew,
aunt, uncle, grandparent, cousin, or half-sibling), the study participant must be 3-20
years of age.
3. Willing to sign Informed Consent Form.
4. Oral glucose tolerance test (OGTT) performed within 7 weeks prior to randomization in
which:
- fasting plasma glucose < 110 mg/dL (6.1 mmol/l), and
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
5. mIAA confirmed positive within the previous six months.
6. Two samples with at least one autoantibody other than mIAA positive within the
previous six months.
Exclusion Criteria:
1. Does not satisfy the above inclusion criteria. Subjects with mIAA positive but no
other autoantibodies positive are not eligible for randomization.
2. Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary,
renal, hepatic, immune deficiency and/or disease that is likely to limit life
expectancy or lead to therapies such as immunosuppression during the time of the
study.
3. Prior participation in a trial for prevention of T1DM, e.g. nicotinamide, insulin,
immunosuppressive drugs.
4. History of treatment with insulin or oral hypoglycemic agent.
5. History of therapy with immunosuppressive drugs or glucocorticoids within the past two
years for a period of more than three months.
6. Ongoing use of medications known to influence glucose, i.e. sulfonylureas, growth
hormone, metformin, anticonvulsants, thiazide or potassium depleting diuretics, beta
adrenergic blockers, niacin. Subjects on such medications should be changed to a
suitable alternative, if available, and will become eligible one month after
medication is discontinued.
7. Pregnant or intends to become pregnant while on study or lactating.
8. Deemed unlikely or unable to comply with the protocol.
9. OGTT that reveals Diabetes, Impaired Glucose Tolerance (IGT), or Impaired Fasting
Glucose (IFG).
Diabetes is defined by:
- fasting plasma glucose ³ 126 mg/dL (7 mmol/l), OR
- 2 hour plasma glucose ³ 200 mg/dL (11.1 mmol/l)
IGT is defined by:
- fasting plasma glucose < 126 mg/dL (7 mmol/l), and
- 2 hour plasma glucose 140-199 mg/dL (7.8 - 11mmol/l),
IFG is defined by:
- fasting plasma glucose 110-125 mg/dL (6.1-6.9 mmol/l) AND
- 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
10. Subject has HLA DQA1*0102, DQB1*0602 haplotype.
Ages Eligible for Study
3 Years - 45 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alison Rigby
6504984450
I'm interested