A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with Cystic Fibrosis-Related Diabetes
Phase 3
Completed
- Conditions
- Cystic Fibrosis1003868610018424
- Registration Number
- NL-OMON38078
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
Adult cystic fibrosis patients (> 18 years)
Diagnosed with cystic fibrosis-related diabetes for at least 6 months
Exclusion Criteria
Pregnancy
Pregnancy wish
Lactation
Organ transplantation in past
On waiting list for transplantation
Proven cystic fibrosis related liver disease or other hepatic disease
Proven type 1 diabetes mellitus
Patients with increased risk on lactate acidosis
Renal insufficiency (creatinine clearance < 50 ml/min (Cockcroft gault))
Sepsis
Alcohol abuse
Use of ACE-inhibitors
Severe cardiovascular disease
Permanent oxygen use
FEV1 % predicted <30 %
BMI < 19
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Insulin need in number of units per day and blood HbA1c levels. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Results from a three-day continuous glucose monitoring, body weight, and<br /><br>overall clinical status, expressed as pulmonary functions, number of pulmonary<br /><br>exacerbations, and antibiotics use.<br /><br>Results from a validated quality of life questionnaire for CF patients.<br /><br>Insulin sensitivity determined by HOMA-IR.</p><br>