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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:
ClinicalTrials.gov Identifier:
NCT01784965
First Posted: February 6, 2013
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerald M Reaven, Stanford University
  Purpose

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.


Condition Intervention Phase
Pre-diabetes Older Adults Drug: liraglutide Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Gerald M Reaven, Stanford University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 69
Study Start Date: December 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
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.
Active Comparator: liraglutide
Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784965


Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Gerald M Reaven, M.D. Stanford University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerald M Reaven, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT01784965     History of Changes
Other Study ID Numbers: 17394
First Submitted: February 4, 2013
First Posted: February 6, 2013
Results First Submitted: March 14, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Weight Loss
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Hyperglycemia
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists