The Rimonabant in treatment of Prediabetes Study: a randomised clinical trial of Rimonabant in the treatment of patients with Prediabetes - Rimonabant Study

Phase 1

• Conditions: MedDRA version: 9.1 Level: LLT Classification code 10000146 Term: Abnormal glucose tolerance test (excl DM); MedDRA version: 9.1 Level: LLT Classification code 10056997 Term: Impaired fasting glucose; Impaired Glucose tolerance and Impaired fasting Glycaemia (Together known as Prediabetes)

• Registration Number: EUCTR2007-000940-28-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-26
• Study Completion: 2010-01-15
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1) Consenting Male or female participants aged 25 to 75 years of Age
2) BMI > 27.5 kg/m2 in South Asians, BMI >30 in White Europeans.
3) Confirmed with Impaired Glucose tolerance and/or Impaired fasting glucose by OGTT using WHO criteria.
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

1) Pregnant or breast feeding women,
2) Absence of medically approved contraceptive usage in women of child bearing age
3) History of eating disorders
4) Known severe renal or hepatic impairment
5) People with cardiac failure
6) Severe psychiatric disorders defined as depression requiring hospitalization in the past or suicidal attempt in the past
7) Housebound
8) Terminally ill or already diagnosed with diabetes mellitus
9) People currently on or in previous 3 months on anti-obesity medication.
10) People unable to offer informed consent

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: The primary outcome will be the change in HOMA-IR in the intervention and control arms after 12 months of trial medication.<br> ;<br> Secondary Objective: Secondary outcomes will include changes in weight, waist and hip circumference, proportion with Metabolic Syndrome (Met S), levels of inflammatory biomarkers, lipid profile, pulse wave velocity ( PWV), Liver function tests(LFT) especially Alanine amino transferase (ALT) and Gamma Glutamyl transferase (GGT).<br> ;Primary end point(s): Primary end point is change in Insulin Resistance as determined by Homeostatic model assesment of Insulin Resistance. (HOMA-IR) This is a validated method of determining Insulin resistance using Fasting Plasma Glucose and Insulin levels applied to a standerdised equation.