A double-blind, placebo-controlled crossover trial to quantify the effects of sibutramine on energy intake and energy expenditure in obese subjects during a test meal - Sibutramine effects on energy balance in obesity

Phase 1

• Conditions: Obesity defined as BMI > 30 kg /m2; Classification code 10029883

• Registration Number: EUCTR2005-002080-88-GB
• Lead Sponsor: Aintree Hospitals NHS Trust and University of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-16
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. Obesity with a body mass index (BMI)>30 kg/m2 and less than 40kg /m2
2. Female, otherwise healthy
3. Age 18-60
4. Must be post-menopausal or sterilised or using a reliable form of contraception

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diabetes
2. Use of other weight loss medication or any drug that might affect body weight or appetite (including anti-depressants, antipsychotics, beta-blockers, corticosteroids)
3. Hyperthyroidism
4. Hypothyroidism (subjects with a normal TSH and free T4, and on a stable dose of thyroxine for at least 3 months may be included)
5. Uncontrolled hypertension (blood pressure >140/90 mmHg)
6. History of ischaemic heart disease or stroke
7. Significant cardiac dysrhythmias
8. Known chronic liver disease
9. Known renal failure
10. Gilles de la Tourette syndrome
11. Known phaeochromocytoma
12. History of seizures or unexplained syncope
13. Pregnancy
14. History of intolerance to sibutramine or any of its constituents
15. Recent major change in body weight (> 3kg loss or gain in preceding month)
16. History of malignancy
17. Presence of any other medical condition that would, in the opinion of the investigator preclude safe participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified