Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.

Phase 3

Completed

• Conditions: Pre-diabetes; Older Adults
• Interventions: Drug: Placebo; Drug: liraglutide

• Registration Number: NCT01784965
• Lead Sponsor: Stanford University

Brief Summary

The goal of this study is to evaluate the hypothesis that the addition of liraglutide, a long-acting glucagon-like peptide 1 (GLP-1) analogue, to a calorie-restricted diet will lead to greater weight loss than will a calorie-restricted diet alone in subjects who are older (50 to 60 years of age), overweight/obese, and prediabetic. These individuals have been selected for study because they are at greatly increased risk to develop type 2 diabetes (2DM) and cardiovascular disease (CVD), and it is hypothesized that the addition of liraglutide to a calorie-restricted diet will significantly decrease risk of these adverse outcomes.

There is considerable evidence that GLP-I compounds, including liraglutide, improve glycemic control in patients with manifest 2DM. However, there is relatively little information as to the potential utility of these compounds in nondiabetic individual at greatly increased risk of 2DM and CVD. This research proposal is aimed at providing some of this information by quantifying the effects of liraglutide, a long-acting GLP-1 analogue, on weight loss, insulin secretion, insulin action, and multiple CVD risk factors in a very high risk group-older, overweight/obese, prediabetic individuals. Furthermore, by using specific methods, not surrogate estimates, and avoiding the confounding effects of glucotoxicity, it will be possible to gain new insights into the effects of GLP-1 on insulin secretion and insulin action.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-06
• Results First Submitted: 2016-03-14
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-15
• Last Update Submitted: 2017-03-15
• Results First Posted: 2017-04-21
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

IFG, or IGT BMI 27.0-37.0 kg/m2

Exclusion Criteria

DM, CAD, severe anemia, kidney or liver disease, hx of pancreatitis, gallstones, ETOH abuse, personnel or family history of medullary thyroid carcinoma or MEN-2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
liraglutide	liraglutide	Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo

Primary Outcome Measures

Name	Time	Method
Change in Weight Reported at 14 Weeks	Baseline and 14 weeks	Change in weight with caloric restriction plus liraglutide vs. caloric restriction and placebo over 14 weeks.

Secondary Outcome Measures

Name	Time	Method
Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H	Baseline, 14 weeks	Absolute change in glucose-stimulated insulin secretion (GS-IS) associated with caloric restriction plus liraglutide vs. caloric restriction and placebo at 14 weeks
Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction	Baseline, 14 weeks	Mean (+/- SD) change in insulin resistance associated with caloric restriction plus liraglutide vs. caloric restriction and placebo.