A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes
Phase 1
- Conditions
- Individuals with cystic fibrosis develop diabetes. They exhibit abnormal glucose handling (impaired glucose tolerance), poor growth and a decline in lung function before overt diabetes develops. Early treatment with insulin before diabetes develops may improve weight gain and lung function and delay progression to overt diabetes.
- Registration Number
- EUCTR2005-002997-31-GB
- Lead Sponsor
- Sheffield Children's NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Any individual with cystsic fibrosis aged 10 years or older who has impaired glucose tolerance following a standard oral glucose tolerance test (OGTT):
- fasting glucose >6.1 mmol but <7.0 mmol
- 2 hour glucose >7.8mmol but < 11.1mmol
- 3 random glucose measurement >1.1mmol but non diabetic OGTT
Are the trial subjects under 18? yes
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
Failure to give informed consent
Previous treatment with insulin or hypoglycaemic agents
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Secondary Objective: To identify aspects of abnormal glucose handling and beta cell function that predict future diabetes.<br> ;<br> Primary end point(s): 1) Change in lung function (FEV1, FVC, Shwachmann score)<br> 2) Change in BMI standard deviation score and growth velocity<br> ;<br> Main Objective: To examine whether treatment with a long acting insulin analogue in the prediabetic phase improves growth & lung function and whether it delays progression to the development of overt diabetes in cystic fibrosis<br><br>
- Secondary Outcome Measures
Name Time Method