Pharmacodynamic Effects of Sibutramine on Gastric Function in Obesity
|ClinicalTrials.gov Identifier: NCT00330525|
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : January 20, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Overweight||Drug: sibutramine||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pharmacodynamic Effects of Sibutramine on Gastric Function in Obesity|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330525
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Michael Camilleri, M.D.||Mayo Clinic|