A study investigating rimonabant and diet in overweight subjects

A study investigating rimonabant versus placebo in conjunction with a strict low-fat weight reduction diet in overweight and obese subjects: effects on glucose and lipid metabolism and cardiovascular risk

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN00253207

Enrollment

Registered

2008-09-12

Start date

2008-08-01

Completion date

Unknown

Last updated

2018-02-12

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

Conditions

Overweight and obese subjects at risk of type 2 diabetes Nutritional, Metabolic, Endocrine Obesity

Interventions

Subjects will be randomised to one of two arms. Study arms are identical in their strict low fat weight reduction diet but will differ in medication. Subjects on one arm will take 20 mg rimonabant (

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females, age >18 years 2. Body mass index (BMI) >27 kg/m^2;Inclusion criteria: 1. Both males and females, age >18 years 2. Body mass index (BMI) >27 kg/m^2

Exclusion criteria

Exclusion criteria: 1. Pregnant women/ breastfeeding mothers 2. Women of childbearing age unwilling to use appropriate contraception 3. Subjects with history of depression or anxiety 4. Subjects with history of significant cardiac, renal or hepatic dysfunction 5. Subjects concurrently on weight loss medication;Exclusion criteria: 1. Pregnant women/ breastfeeding mothers 2. Women of childbearing age unwilling to use appropriate contraception 3. Subjects with history of depression or anxiety 4. Subjects with history of significant cardiac, renal or hepatic dysfunction 5. Subjects concurrently on weight loss medication

Design outcomes

Primary

Measure	Time frame
The following will be assessed at baseline and 8 weeks (end of interventions): 1. Insulin resistance, assessed using the euglycaemic hyperinsulinaemic glucose clamp technique 2. Weight;The following will be assessed at baseline and 8 weeks (end of interventions): 1. Insulin resistance, assessed using the euglycaemic hyperinsulinaemic glucose clamp technique 2. Weight	—

Secondary

Measure	Time frame
The following will be assessed at baseline and 8 weeks (end of interventions): 1. Meal tolerance tests 2. Glycaemic control 3. Vascular compliance 4. Body composition 5. Plasma lipids 6. Adipokines 7. Fat biopsies;The following will be assessed at baseline and 8 weeks (end of interventions): 1. Meal tolerance tests 2. Glycaemic control 3. Vascular compliance 4. Body composition 5. Plasma lipids 6. Adipokines 7. Fat biopsies	—

Measure

Time frame

The following will be assessed at baseline and 8 weeks (end of interventions): 1. Meal tolerance tests 2. Glycaemic control 3. Vascular compliance 4. Body composition 5. Plasma lipids 6. Adipokines 7. Fat biopsies;The following will be assessed at baseline and 8 weeks (end of interventions): 1. Meal tolerance tests 2. Glycaemic control 3. Vascular compliance 4. Body composition 5. Plasma lipids 6. Adipokines 7. Fat biopsies

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Countries

United Kingdom

Contacts

Public Contact; ;

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Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026