Pharmacodynamic Effects of Sibutramine on Gastric Function in Obesity

Phase 2

Completed

• Conditions: Obesity; Overweight

• Registration Number: NCT00330525
• Lead Sponsor: Mayo Clinic

Brief Summary

Control of food intake, size and frequency of meals are critical to the development of obesity. The stomach signals feelings of fullness after a meal and therefore plays a role in control of calorie intake. It is unclear whether the approved appetite reducing drug sibutramine changes the function of the stomach. Differences in the way individuals respond to treatment with the appetite suppressant sibutramine may also explain why some people lose weight while others do not.

This single center clinical study aims to compare functions of the stomach in healthy, overweight and obese individuals, and to evaluate the effects of the FDA-approved appetite suppressing medication sibutramine on weight loss and stomach functions in patients who are overweight or obese. The effect of individual differences in inherited genes on weight reduction with sibutramine will be tested.

Detailed Description

Background: Control of food intake, size and frequency of meals are critical to the development of obesity. The stomach signals satiation in response to calories and volume ingested, playing a role in control of calorie intake. It is unclear whether the approved appetite reducing drug sibutramine alters gastric physiology. Genetic variations are potentially key to inter-individual differences in responses to treatment with the appetite suppressant sibutramine.

Aims: 1. To compare gastric functions in healthy, overweight and obese individuals. 2. To evaluate effects of sibutramine on gastric functions and weight in patients who are overweight or obese. 3. To obtain preliminary data on the effect of genetic variation on responses to sibutramine.

Methods: We shall measure gastric emptying, fasting and postprandial gastric volumes (using validated, non-invasive imaging methods), postprandial satiation and satiety, and integrated plasma ghrelin, leptin, insulin, GLP-1 and peptide YY levels before and after 12 weeks of sibutramine 15mg vs. placebo. We shall also collect DNA, to eventually study effects of candidate genes on response to sibutramine.

Significance: Our study will provide the first evidence of the effects of sibutramine on gastric function.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2006-05-25
• Study First Submitted QC: 2006-05-25
• Study First Posted: 2006-05-29
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-19
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
T1/2 gastric emptying of solids and liquids
Fasting whole gastric volume
Maximum volume of Ensure ingested (satiety testing)
weight loss in kg
effect of candidate SNPs/gene deletions on response to sibutramine

Secondary Outcome Measures

Name	Time	Method
Ghrelin, leptin, insulin, GLP-1, and PYY levels integrated over the 8 hours after the meal.
Aggregate symptom score 30 min after ingestion of Ensure
Body fat
Gastric residual at 2 and 4 hours; gastric emptying T10%, and parameters from power exponential analysis will also be described
Caloric intake from a standard ad libitum meal

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States