Obesity Clinical Trial
Official title:
Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity
This study was being done to assess the stomach emptying effect of a maximum dose of 3 mg Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use.
The objective of this study was to compare effects of liraglutide and placebo over 16 weeks
on gastric motor functions, satiation, satiety and weight in obese patients. Subjects were
randomized to liraglutide or placebo. Liraglutide or placebo was escalated by 0.6mg/day each
week for 5 weeks and continued until week 16. At baseline and after 16 weeks' treatment, the
investigators measured weight, gastric emptying of solids (GES), gastric volumes, satiation
(maximum tolerated volume of liquid nutrient drink), and satiety. GES was also measured at 5
weeks.
During the study, the subjects received standardized dietetic and behavioral advice for
weight reduction therapy. All subjects were given a standard text for information and met
with a behavioral psychologist who has expertise in obesity treatment at the baseline visit
and at visits at weeks 4,8, and 12. Additionally, the subjects had brief contact with a
member of the study team every 4 weeks to inquire about their adherence to study protocol,
any difficulties they were experiencing, whether they were reading their text assignments,
and to answer any additional questions.
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