Pharmacodynamic Effects of Sibutramine on Gastric Function in Obesity

NCT00330525 | Completed Phase 2

• 1 other identifier: 1723-04
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• 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

Interventions

sibutramine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age: 18-65 years
• Gender: Men or women. Women of childbearing potential will have negative pregnancy test within 48 h of enrollment and before each radiation exposure.

You may not qualify if:

• Weight exceeding 300 pounds or 137 kilograms (due to limitations regarding SPECT imaging studies).
• Abdominal surgery other than appendectomy, Caesarian section or tubal ligation.
• 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\).
• 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.
• 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.
• Concomitant use of MAOI inhibitors and other centrally acting appetite suppressants (since this would make them ineligible for sibutramine treatment).
• Hypersensitivity to sibutramine (since this would make them ineligible for sibutramine treatment).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

sibutramine

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Camilleri, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2006
• First Posted: May 29, 2006
• Study Start: January 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: January 20, 2010

Record last verified: 2010-01

Locations

US (1)