treatment with insulin in patients with cystic fibrosis without diabetes

Conditions: cystic fibrosis patients without cystic fibrosis related diabetes
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-001916-69-NL

Lead Sponsor: HagaZiekenhuis, pulmonary department

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patients>18 years diagnosed with cystic fibrosis, a normal glucose tolerance test, exocrine pancreatic insufficiency.
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

pregnancy, pregnancy wish, lactation, history of organ transplantation, high urgency status on waiting list for transplantation, use of systemic corticosteroids within one mont before of during the study period, malignancy, distal intestinal obstruction syndrome (DIOS) or pulmonary exacerbation with hospital admission one month before or during the study period, use of appetite stimulants.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: investigate the effect of low dose insulin therapy on nutritional status en body weight,.;Secondary Objective: investigate the effect of insulin on pulmonary function and quality of life.;Primary end point(s): body weight, body mass index;Timepoint(s) of evaluation of this end point: end of study period ( 24 weeks)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): pre-albumin levels, vitamin status, pulmonary function, number of exacerbations, antibiotic use, Fat free mass index. ESR, CRP, leucocytes, quality of life on a validated quality of life questionnaire for CF.;Timepoint(s) of evaluation of this end point: end of study period ( 24 weeks)