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

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	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Pre-diabetes Weight Control

Drug Information available for: Glucagon Liraglutide

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

To compare the magnitude of weight loss associated with caloric restriction plus liraglutide vs. caloric restriction alone (with placebo). [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
To compare degree of change in insulin resistance associated with caloric restriction plus liraglutide vs. caloric restriction alone (with placebo). [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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
Active Comparator: liraglutide Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo	Drug: liraglutide

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784965

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Gerald M Reaven, M.D.

Stanford University

More Information

No publications provided

Responsible Party:	Gerald M Reaven, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier:	NCT01784965 History of Changes
Other Study ID Numbers:	17394
Study First Received:	February 4, 2013
Last Updated:	February 4, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:

Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Weight Loss
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes

Body Weight
Signs and Symptoms
Hyperglycemia
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013