Effect of Liraglutide (Victoza) on Inflammation in Human Adipose Tissue and Blood

Not Recruiting

Trial ID: NCT02650206

Purpose

The objective of this study is to test the hypothesis that liraglutide (commonly known as Victoza) can promote an anti-inflammatory macrophage phenotype in human adipose tissue and blood, thereby reducing localized and systemic inflammation which are risk factors for cardiovascular disease and may contribute to hyperglycemia. This will be done after 4 weeks of treatment during which weight will remain stable, and again after 12 weeks, during which liraglutide-related weight loss occurs.

Official Title

Effect of Liraglutide on Macrophage Polarization in Human Adipose Tissue and Peripheral Blood

Stanford Investigator(s)

Tracey McLaughlin
Tracey McLaughlin

Professor of Medicine (Endocrinology)

Eligibility


Inclusion Criteria:

   - BMI between 25 and 42 kg/m2

   - Diet-controlled diabetics, or diabetics on Metformin that have permission from Primacy
   Care Physician to wash-out of the drug for 6 weeks prior to the study and for the
   duration of the study

   - HbA1C between 6.0 - 7.9 (those on Metformin must have a HbA1c level below 7.5 prior to
   wash-out period)

   - Fasting Blood Glucose < 150 mg/dl

   - Women must be post-menopausal or surgically sterile within age range

   - Subjects must live in vicinity of Stanford University

Exclusion Criteria:

   - Prior Bariatric surgery

   - Personal or family history of medullary thyroid cancer

   - MEN2 Syndrome

   - Thyroid Nodules (not evaluated by PCP)

   - Pancreatitis (acute or chronic)

   - Gallstones

   - Fasting plasma triglycerides > 400 mg/dl

   - Cardiovascular disease

   - Major organ disease

   - Unstable hypertension (BP >160/100 mm Hg)

   - Heavy alcohol use

   - Self-reported weight change of >2kg over past 6 weeks

   - Medication known to affect blood glucose, insulin sensitivity, or inflammation

   - NSAIDs (must cease use 4 weeks prior to study enrollment)

   - Previous use of liraglutide, Januvia, Byetta, or Lira.

Intervention(s):

drug: Victoza (liraglutide) with dietician monitoring

other: Placebo with dietician monitoring

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth A Colbert, BA
650-736-2056