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Orlistat Body Composition Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by GlaxoSmithKline.   Recruitment status was  Recruiting

First Received on September 11, 2008.   Last Updated on September 18, 2008   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00752726
  Purpose

Weight loss is associated with changes in body composition. The purpose of this study is to determine if a 24 week weight loss program with orlistat 60 mg will produce greater changes in body composition compared to placebo. This study will use the Echo MRI technology across multiple sites to measure total fat mass.


Condition Intervention Phase
Overweight
Drug: orlistat
Phase IV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effects of Weight Reduction With Orlistat vs. Placebo on Changes in Body Composition

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Abdominal visceral adipose tissue (VAT) mass

Secondary Outcome Measures:
  • Body weight, total fat mass, liver fat (IHL), waist circumference, percent body fat, physical activity and quality of life, selectivity index, safety and tolerability

Estimated Enrollment: 120
Study Start Date: September 2008
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Aged 18-60 years inclusive
  2. Body Mass Index (BMI): BMI in the range of 25.0-34.9 kg/m2 Approximately 1/3 of patients BMI between 25.0-27.9 kg/m2 Approximately 2/3 of patients BMI between 28.0-34.9 kg/m2
  3. Waist circumference:

Females: > 35 inches Males: > 40 inches

4)Diet

a) Normal eating habits, consuming 3 meals a day (breakfast, lunch and dinner) b) Willing to follow a hypocaloric diet during the study to achieve weight loss c) Willing to take a daily multivitamin for the duration of the study.

5)General Health Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination Exclusion Criteria

  1. Pregnancy Women who are known to be pregnant, have a positive pregnancy test, or who are intending to become pregnant over the duration of the study.
  2. Breast-feeding Women who are breast-feeding
  3. Diet/Exercise Currently on a special diet or who cannot fulfill the dietary requirements of the study.
  4. Smoking History

    1. Smoking cessation within the past 6 months
    2. Current Smokers
  5. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials and study foods (or closely related compounds) or any of their stated ingredients.
  6. Medication

    1. Currently taking medication for weight loss or appetite control.
    2. Previous Xenical® (orlistat) or alli® use within 3 months of screening date
    3. Currently taking medication or supplements that influence intestinal transit time and other stool formation parameters or influences cramping (e.g., Anticholinergics (such as atropine) or cholinergics (such as physostigmine), phenothiazines, tricyclic antidepressants, opioid analgesics (including loperamide), calcium channel antagonists, clonidine, cisapride, octreotide. Also, any laxative or antidiarrheal product).
    4. Currently taking or withdrawn during the past 6 months any drugs with significant impact on body weight (e.g. serotoninergically acting drugs, antidepressants, central adrenergically acting drugs, drugs inhibiting digestion and absorption, appetite suppressants, metformin)
    5. Currently taking Cyclosporine, Warfarin or Amiodarone HCL
  7. Disease/Surgery

    1. History of gastrointestinal disease (e.g., irritable bowel syndrome, diarrhea, inflamed bowel, steatorrhea/fat malabsorption, hemorrhoids, incontinence, pancreatitis).
    2. History of psychological disorder, including eating disorders such as anorexia nervosa and bulimia
    3. History of neurological disorder (e.g. seizures, parkinson's disease, Alzheimer's disease)
    4. History of hypo/hyperthyroidism unless euthyroid and controlled on a stable dose of medication for at least 6 months.
    5. History of surgery for weight loss
    6. Uncontrolled hypertension
    7. Heart Disease
    8. Diabetes Mellitus (Type 1 and 2) (Fasting Blood Glucose >126 mg/dL)
  8. Subject has a known history of panic attacks and/or claustrophobia or other conditions precluding safe EchoMRI, CT or other scanning modalities according to local guidelines, (e.g., pacemaker, hearing aid, metallic body piercing and/or other metal implants) or in the opinion of the Investigator the subject exceeds size limitations for the instruments.
  9. Subject has had a weight loss or gain of greater than or equal to 3 kg in the 3 months prior to screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752726

Locations
United States, Louisiana
GSK Investigational Site Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: GSK Call Center     877-379-3718        
United States, North Carolina
GSK Investigational Site Not yet recruiting
Durham, North Carolina, United States, 27708
Contact: GSK Call Center     877-379-3718        
Sweden
GSK Investigational Site Not yet recruiting
Gothenburg, Sweden, SE 405 30
Contact: GSK Call Center     1-877-379-3718        
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GlaxoSmithKline Clinical Trials, PharmD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00752726     History of Changes
Other Study ID Numbers: W3600586
Study First Received: September 11, 2008
Last Updated: September 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Body composition
orlistat
weight loss

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012