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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerald M Reaven, Stanford University
ClinicalTrials.gov Identifier:
NCT01784965
First received: February 4, 2013
Last updated: March 15, 2017
Last verified: March 2017

February 4, 2013
March 15, 2017
December 2009
December 2012   (Final data collection date for primary outcome measure)
Change in Weight Reported at 14 Weeks [ Time Frame: Baseline and 14 weeks ]
Change in weight with caloric restriction plus liraglutide vs. caloric restriction and placebo over 14 weeks.
To compare the magnitude of weight loss associated with caloric restriction plus liraglutide vs. caloric restriction alone (with placebo). [ Time Frame: 3 years ]
Complete list of historical versions of study NCT01784965 on ClinicalTrials.gov Archive Site
  • Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H [ Time Frame: 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 [ Time Frame: Baseline, 14 weeks ]
    Mean (+/- SD) change in insulin resistance associated with caloric restriction plus liraglutide vs. caloric restriction and placebo.
  • To compare the degree of change in glucose-stimulated insulin secretion (GS-IS) associated with caloric restriction plus liraglutide vs. caloric restriction alone (with placebo). [ Time Frame: 3 years ]
  • To compare degree of change in insulin resistance associated with caloric restriction plus liraglutide vs. caloric restriction alone (with placebo). [ Time Frame: 3 years ]
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Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.
Addition of a Glucagon-like Peptide-1 to a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and Cardiovascular Disease.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Prevention
  • Pre-diabetes
  • Older Adults
  • Drug: liraglutide
    Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.
    Other Name: Victoza
  • Drug: Placebo
    Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.
  • Placebo Comparator: placebo
    Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
    Intervention: Drug: Placebo
  • Active Comparator: liraglutide
    Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
    Intervention: Drug: liraglutide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
December 2012
December 2012   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
40 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01784965
17394
No
Not Provided
No
Not Provided
Gerald M Reaven, Stanford University
Stanford University
Not Provided
Principal Investigator: Gerald M Reaven, M.D. Stanford University
Stanford University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP