Diabetes therapy to improve body mass index pulmoanry function in cystic fibrosis subjects with abnormal blood glucose
Phase 1
- Conditions
- Cystic fibrosis related diabetes mellitus
- Registration Number
- EUCTR2004-005019-28-GB
- Lead Sponsor
- Papworth Hospital NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
Aged 18-65
Cystic fibrosis
Normal fasting glucose (<126 mg/dl) but a diabetic OGTT >200mg/dl and patients whose two hour OGTT glucose is >140-200mg/dl and also have a glucose level during OGTT >200mg/dl within the last 12 months.
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
Acute illness within the last 12 months
Current treatment with glucocorticoids
Fasting hyperglycaemia >126mg/dl on more than two ocassions in past 12 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish if an anti glycaemic induced increase in body mass index improves the pulmonary function of cystic fibrosis patients;Secondary Objective: Nil;Primary end point(s): FEV1
- Secondary Outcome Measures
Name Time Method