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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type II, Diabetes Mellitus, Adult-Onset, Inflammation

In brief

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.

Key facts

Study ID

NCT02650206

Run by

Stanford University

People needed

56

Starts

2015-01-01

Expected to finish

2019-09-27

Last updated by the study team

2020-06-09

Who can join

Age: 40 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Freidenrich Center for Translational Research (FCTR) — Stanford, California, United States

Full record on ClinicalTrials.gov

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