CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 600

Inclusion Criteria

We aim to include people who fulfil at least the following inclusion criteria:
1. Informed consent must be obtained in writing for all subjects at enrolment into the study
2. Male or female 18 to 75 years of age
3. Willingness and ability to comply with the study protocol (including the lifestyle counselling)
4. Waist circumference more than 88 cm in women and more than 102 cm in men
5. Diabetes mellitus type two or an impaired fasting blood glucose more than 6.1 mmol/l in venous plasma

Exclusion Criteria

Participants are excluded from participation in the study if:
1. Pregnant or breast-feeding women, or women planning to become pregnant
2. Previous use of rimonabant
3. History of surgical procedures for weight loss (e.g., stomach stapling, bypass)
4. Morbid obese patients (Body Mass Index [BMI] more than 40 kg/m^2), history of bulimia or anorexia nervosa
5. Presence of any clinically significant endocrine disease
6. Severe renal dysfunction (creatinine clearance more than 30 ml/min) or nephrotic syndrome
7. Known chronic hepatitis or clinically significant hepatic disease
8. Significant haematology abnormalities (haemoglobin less than 100 g/L and/or neutrophils less than 1.5 G/L and/or platelets less than 100 G/L)
9. Cardiac status New York Heart Association (NYHA) III or IV or Electrocardiogram (ECG) within six months showing acute changes
10. Any current malignancy or any cancer with the past five years (except adequately treated basal cell skin cancer or cervical carcinoma in situ)
11. History of seizure disorder
12. Acute psychiatric disorders or prolonged use within the last three months of neuroleptics
13. History of severe depression that could be defined as depression which necessitated the patient to be hospitalised, or patients with two or more recurrent episodes of depression or a history of suicide attempt and/or prolonged use (more than one week) within the last three months use of antidepressants (including bupropion)
14. History of alcohol or other substance abuse, use of hashish or marijuana use
15. Use of any investigational treatment (drug or device) within 30 days prior to screening
16. Prolonged use (more than one week) within the last three months of systemic corticosteroids

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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