Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433641
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
2007-02-08
Brief Title:
Weight Loss in Response to Sibutramine MERIDIA is Influenced by the Inherited Genes
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Pharmacogenomics of Weight Loss With Sibutramine in Obese and Overweight Patients
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
In a previous study of 48 overweight or obese participants we preliminarily observed that variation in the gene for the promoter of the serotonin transporter protein was significantly associated with degree of weight loss
This new single center clinical study aims to evaluate the effects of the FDA-approved appetite suppressing medication sibutramine MERIDIAon weight loss and stomach emptying in patients who are overweight or obese The effect of individual differences in inherited genes that modify serrotonin and noradrenergic receptors on weight reduction with sibutramine will be tested
In a previous study of 48 overweight or obese participants we preliminarily observed that variation in the gene for the promoter of the serotonin transporter protein was significantly associated with degree of weight loss
This new single center clinical study aims to evaluate the effects of the FDA-approved appetite suppressing medication sibutramine MERIDIAon weight loss and stomach emptying in patients who are overweight or obese The effect of individual differences in inherited genes that modify serrotonin and noradrenergic receptors on weight reduction with sibutramine will be tested
Detailed Description:
Background Genetic variations are potentially key to inter-individual differences in responses to treatment with the appetite suppressant sibutramine
Overall Aims To evaluate influence of genetic variation in candidate adrenergic and serotonergic control mechanisms on weight loss and gastric emptying response to sibutramine in obesity
Methods 180 overweight or obese respectively BMI of 25-299 or 30 kgm2 people treated with sibutramine 10 or 15 mgday or placebo for 12 wks We shall collect DNA from venous blood sample at study entry and use SERT-P genotype at baseline to stratify patients according to LL vs LSSS genotype in both obese and overweight groups The primary outcome measurement will be the association of clinical response weight loss and the influence of SERT-P and 2-MSP variation A secondary outcome for descriptive purposes is the gastric emptying response to sibutramine treatment Gastric emptying of solids will be measured using stable isotope method
Anticipated Results SERT-P genotype is significantly associated with the magnitude of weight loss in obese and overweight individuals
Significance Our study will provide the first evidence of the pharmacogenomic effects of sibutramine on weight loss in obesity and appraise the association of weight loss with change in gastric emptying
Overall Aims To evaluate influence of genetic variation in candidate adrenergic and serotonergic control mechanisms on weight loss and gastric emptying response to sibutramine in obesity
Methods 180 overweight or obese respectively BMI of 25-299 or 30 kgm2 people treated with sibutramine 10 or 15 mgday or placebo for 12 wks We shall collect DNA from venous blood sample at study entry and use SERT-P genotype at baseline to stratify patients according to LL vs LSSS genotype in both obese and overweight groups The primary outcome measurement will be the association of clinical response weight loss and the influence of SERT-P and 2-MSP variation A secondary outcome for descriptive purposes is the gastric emptying response to sibutramine treatment Gastric emptying of solids will be measured using stable isotope method
Anticipated Results SERT-P genotype is significantly associated with the magnitude of weight loss in obese and overweight individuals
Significance Our study will provide the first evidence of the pharmacogenomic effects of sibutramine on weight loss in obesity and appraise the association of weight loss with change in gastric emptying
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH DK67071 | None | None | None |