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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20796

Enrollment

600

Registered

2006-09-20

Start date

2006-09-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Participants in the different study groups receive no medication, rimonabant or placebo plus 3 life style counseling sessions

Eligibility

Inclusion criteria

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 enrollment into the study 2. Male or female 18 – 75 years of age 3. Willingness and ability to comply with the study protocol (including the lifestyle counseling) 4. Waist circumference >88 cm in women; >102 cm in men 5. Diabetes mellitus type 2 or an impaired fasting blood glucose > 6.1 mmol/l in venous plasma

Exclusion criteria

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 (eg, stomach stapling, bypass) 4. Morbid obese patients (BMI > 40 kg/m2), history of bulimia or anorexia nervosa 5. Presence of any clinically significant endocrine disease 6. Severe renal dysfunction (creatinine clearance 1 week) within the last 3 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 (> 1 week) within the last 3 months of systemic corticosteroids

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: Primary outcomes will be measured after 3, 6, and 12 months, and include waist circumference, plasma glucose, HbA1C and the use of rimonabant.	—

Secondary

Measure	Time frame
Secondary outcomes will be measured during the visits and at follow-up including lipid profile, body weight, blood pressure, smoking, QALYs and costs.	—

Contacts

Public ContactJ. Kaper

University Maastricht (UM), CAPHRI Research Institute, P.O. Box 616

janneke.kaper@hag.unimaas.nl+31 (0)43 3882420

Outcome results