Cardiovascular Effects of GLP-1 Receptor Activation

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT03101930
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    subcutaneous liraglutide daily
  • Sitagliptin — DRUG
    oral sitagliptin daily
  • hypocaloric diet — OTHER
    Reduced calorie intake to achieve weight loss.
  • Placebos — DRUG
    Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
  • Exendin (9-39) — DRUG
    All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.

Study Details

This project tests the principle hypothesis that stable glucagon like peptide-1 (GLP-1) analogues have specific GLP1R-dependent beneficial effects on vascular endothelial function, fibrinolysis and inflammation in obesity that exceed the benefits of weight loss, and that genetic or other individual factors that modulate GLP1R sensitivity can modify the effect of these analogues on cardiovascular risk.

Key Dates

Start date
May 1, 2017
Status verified
Sep 2022
Primary completion
Jun 24, 2021
Completion
Jun 24, 2021

Study Design

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

Arms

  • Experimental: liraglutide
    Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
  • Active Comparator: sitagliptin
    Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
  • Active Comparator: hypocaloric diet
    Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.

Primary Outcome Measure

Change in Flow-mediated Dilation [ Time Frame: Baseline to 2 and 14 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Nashville, TN

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Vanderbilt University Medical Center· Nashville, TN

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