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Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.
Not Recruiting
Trial ID: NCT01784965
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.
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.
Eligibility
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
Intervention(s):
drug: liraglutide
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305