Effects of Rimonabant on Liver Fat, Visceral Adipose Tissue Mass and early Markers of CardioDiabetes in obese Subjects with the Metabolic Syndrome – a randomized, double-blind clinical trial

• Conditions: overweight, obesity; MedDRA version: 9.1Level: PTClassification code 10033307Term: Overweight

• Registration Number: EUCTR2007-000775-42-DE
• Lead Sponsor: niversity Hospital Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Age: 18 - 70 years, inclusive
Gender: male, female
BMI: 27- 45
Metabolic syndrome according to the ATP III criteria (any 3 of the following):
Abdominal obesity: waist circumference > 102 cm (men), > 88 cm (women)
Triglyzeride 150 mg/dl
HDL < 40 mg/dl (men), < 50 mg/dl (women)
Blood pressure 130/ 85 mmHg
Fasting glucose 110 mg/dl
Or impaired fasting glucose 5.6 mmol/l and 7.0 mmol/l
Or impaired glucose tolerance : 2-h-glucose (75g OGTT) 7.8 mmol/l and 11.1 mmol/l
Stable weight (+ 5 kg) in the last 6 months
No lifestyle intervention study in the last 6 months
Willing and able to complete screening and study procedures, as described in the protocol
Signed written informed consent to participate in the study

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General health problems (e.g. cancer, cardiovascular events in the past 12 months)
Significant findings indicating: cardiovascular, endocrine, pulmonary, neurologic, psychiatric, gastrointestinal, hepatic, hematologic, renal, or dermatologic disease
Any of the following blood examination results:
Positive hepatitis-B-surface-antigen
Positive hepatitis-C antibody
Positive HIV-antibodies
Abnormal thyrotropin level
GPT, GOT > 2.5 times the upper limit of the normal range
Haemoglobin levels < 11 g/dl
Neutrophil levels < 1500 /mm3
Platelet levels < 100.000/ mm3
Creatinine level > 150 ?mol/l
Any positive history of marijuana or hashish use, no matter how long ago or a positive drug test for marijuana or hashish
Acutal misuse of other drugs
Severe depression (requiring hospitalization or indicated by a suicidal attempt)
Mild or severe depression according to the depression questionnaire (MDI) at screening
Antidepressive pharmacological treatment
Treatment for epilepsy and eating disorder or a malignant disease
Diabetes mellitus (type 1 or 2)
Pharmacological treatment of dyslipidemia within 6 weeks before screening
Pregnancy
Lactation
Systolic blood pressure > 165 mmHg
Diastolic blood pressure > 105 mmHg
Hypersensivity to the active substance or to any of the exipients (see SPC appendix 17.1)
Exclusion criterias for MRT-, 1HMRS- examinations: non-compliance, pace maker, cochlea implant, nerve stimulators, magnetic vascular clips, metallic heart valve or other contraindications for MRT-, 1HMRS- examinations
Patients with lactose intolerance, rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose
Regular use potent CYP3A4 inhibitiors: ketoconazole, itraconazole, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir (protease inhibitors), delavirdin, erythromycin, telithromycin, clarithromycin, nefazodone, cimetidine, fluoxetine, fluvoxamine, paroxetine, sertaline, naringenine (grape fruit juice), verapamile
Potent CYPA3-Inducers: rifampicin, phenytoin, phenobarbital, carbamazepine, St John’s wort
Any Medication containing cannabis

Study & Design

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