Pharmacodynamic Effects of Sibutramine on Gastric Function in Obesity

January 19, 2010 updated by: Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Normal weight, overweight and obese subjects with BMI> 18 Kg/m2 residing in Olmsted County, MN: Otherwise healthy individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than hyperglycemia not requiring medical therapy) and unstable psychiatric disease.
  2. Age: 18-65 years
  3. Gender: Men or women. Women of childbearing potential will have negative pregnancy test within 48 h of enrollment and before each radiation exposure.

Exclusion Criteria

  1. Weight exceeding 300 pounds or 137 kilograms (due to limitations regarding SPECT imaging studies).
  2. Abdominal surgery other than appendectomy, Caesarian section or tubal ligation.
  3. Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility or use of medications that may alter gastrointestinal motility, appetite or absorption e.g., orlistat (Xenical).
  4. Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Scale [HADS] self-administered alcoholism screening test (substance abuse) and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HADS score >8 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
  5. Intake of medication, whether prescribed or OTC medication (except multivitamins) within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, and thyroxine replacement.
  6. Concomitant use of MAOI inhibitors and other centrally acting appetite suppressants (since this would make them ineligible for sibutramine treatment).
  7. Hypersensitivity to sibutramine (since this would make them ineligible for sibutramine treatment).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Body fat
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Michael Camilleri, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

May 25, 2006

First Submitted That Met QC Criteria

May 25, 2006

First Posted (Estimate)

May 29, 2006

Study Record Updates

Last Update Posted (Estimate)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 19, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1723-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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