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Cardiovascular Effects of GLP-1 Receptor Activation

NCT03101930 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 329

Last updated 2022-10-18

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Liraglutide

subcutaneous liraglutide daily

DRUG

Sitagliptin

oral sitagliptin daily

OTHER

hypocaloric diet

Reduced calorie intake to achieve weight loss.

DRUG

Placebos

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.

DRUG

Exendin (9-39)

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.

Sponsors & Collaborators

Principal Investigators

  • James M. Luther, M.D. · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2021-06-24
Completion
2021-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03101930 on ClinicalTrials.gov