Ronald Witteles
Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients with Heart Failure
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. This study will also investigate the effect of sitagliptin on the body's use of sugar, and of the effect of sitagliptin on blood flow to the heart.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Sitagliptin therapy
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
a) Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-III congestive heart failure
b) Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or anigotensin receptor blockers unless intolerant)
d) Age > 18 yrs
Key Exclusion Criteria:
1) Cardiomyopathy primarily due to one of the following:
a. Ischemic heart disease
b. Primary valvular lesion
c. Hypertrophic cardiomyopathy
2) Cardiac resynchronization within the last 3 months
3) Calculated creatinine clearance <30 ml/min or end-stage renal disease on dialysis. Creatinine clearance will be determined by the Cockroft-Gault formula.
4) Diagnosis of diabetes mellitus by:
a. Diabetes previously diagnosed per patient history
b. 2 or more fasting glucose values > 125 mg/dl
5) History of heart transplantation
6) Pregnancy or active breast feeding
7) Hospitalization for decompensated heart failure within 30 days prior to enrollment.
Additional Study Details
Official Title:
Effect of Sitagliptin on Insulin Resistance and Myocardial Metabolism in Heart FailureAnticipated start date:
4/8/2008Lead Sponsor:
Stanford UniversityCollaborator(s):
- Merck
Investigator(s):
Study Type:
InterventionalPurpose:
DiagnosticAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Determine the effects of sitagliptin on myocardial glucose uptake in patients with nonischemic cardiomyopathy
Secondary Outcomes:
- Determine the effects of sitagliptin on microvascular function in patients with nonischemic cardiomyopathy
- Determine the effects of sitagliptin on insulin sensitivity in a heart failure population
Total Number to be Enrolled:
16Total Number to be Enrolled at Stanford:
0More Information
Secondary ID(s):
- 11784 (Human Subjects)
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
4/13/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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