Cortisol metabolism and impaired glucose tolerance
Phase 1
- Conditions
- Impared glucose toleranceMedDRA version: 9.1 Level: LLT Classification code 10018429 Term: Glucose tolerance impairedMedDRA version: 9.1 Level: LLT Classification code 10029883 Term: Obesity
- Registration Number
- EUCTR2006-003426-28-GB
- Lead Sponsor
- niversity Hospitals Birmingham NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
BMI > 30kg/m2
Impared glucose tolerance
age 18-65 years
BP < 150/90mmHg (with or without medication)
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Metformin, sulphonylurea, insulin or TZD therapy
Uncontrolled BP >150/90mmHg
Serum potassium <3.5mmol/L
Glucocorticoid use within the last 12 months
Pregnancy or planning pregnancy
Study withdrawal criteria
BP>165/100 at any point during the study
Serum potassium <3.5mmol/L at any point during the study
Adverse drug reaction
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether Carbenoxolone can improve blood glucose control in patients with impared glucose tolerance;Secondary Objective: To determine whether carbenoxolone increases insulin secretion, improves insuiln sensitivity and decreases lipolysis in patients with impared glucose tolerance.;Primary end point(s): The study is of a fixed duration (4 weeks active treatment and 4 weeks placebo)
- Secondary Outcome Measures
Name Time Method