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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT02650206
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Victoza (liraglutide) with dietician monitoring — DRUG
    Victoza (liraglutide), an FDA-approved medication, is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subjects with this intervention will be followed by the MD and dietician throughout the study to monitor progress through 4 week period of weight maintenance and 8 week period of weight loss.
  • Placebo with dietician monitoring — OTHER
    Subjects will not receive the study drug, but will be followed by the MD and dietician throughout the study to monitor progress through 4 week period of weight maintenance and 8 week period of weight loss.

Study Details

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 Dates

Start date
Jan 31, 2015
Status verified
Jun 2020
Primary completion
Sep 27, 2019
Completion
Sep 27, 2019

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Liraglutide group
    Drug with diet control intervention: Subjects assigned to this group receive blinded pens containing liraglutide (commonly known as Victoza), manufactured by Novo Nordisk. Subjects will inject 0.6 mg daily into abdomen during the first week of the study, and if tolerated, will increase dose to 1.2 mg the second week of the study, and then up to 1.8 mg daily from the third week until the end of the 12-week study. Any adverse symptoms as well as fasting blood glucose will be monitored weekly for safety. Subjects, with the guidance of the study's dietitian, will remain weight-stable for the first four weeks of the study, and then will be allowed to lose weight for the remaining eight weeks of the study.
  • Placebo Comparator: Placebo group
    Diet control-only intervention: Subjects assigned to this group receive blinded pens containing placebo (normal saline) instead of liraglutide (commonly known as Victoza). Subjects will inject 0.6 mg of placebo daily during the first week of the study, will increase to 1.2 mg the second week of the study, and then up to 1.8 mg daily from the third week until the end of the 12-week study. Any adverse symptoms as well as fasting blood glucose will be monitored weekly for safety. Subjects, with the guidance of the study's dietitian, will remain weight-stable for the first four weeks of the study, and then will be allowed to lose weight for the remaining eight weeks of the study.

Primary Outcome Measure

Macrophage polarization: % M2 macrophages in adipose tissue and peripheral blood according to positivity for cell surface markers (measured by flow cytometry). [ Time Frame: 30 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Freidenrich Center for Translational Research (FCTR)StanfordCalifornia94305-

Find similar trials in Stanford, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Freidenrich Center for Translational Research (FCTR)· Stanford, CA

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