To investigate the effect of low-dose long acting insulin therapy on nutritional status in adult CF patients without diabetes.
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
body weight and body mass index.
Secondary outcome
Serum pre-albumin/ESR/leucocytes/CRP/vitamin A,D,E,K
pulmonary function
number of pulmonary exacerbations
antibiotic use
quality of life
foodintake
Background summary
Chronic malnutrition with weight loss is a major problem in patients with
Cystic Fibrosis. There is a clear association between malnutrition and impaired
pulmonary and muscle functions, and poorer survival. Nutritional
supplementation is often difficult to accompolish. Several therapies to improve
nutritional state have been studied, most of them were very shortterm and
showed many negative side effects.
Insulin, primarily known as a glucose-lowering agent, is a potent anabolic
hormone which acts on a range of carbohydrate, fat and protein metabolisms.
Previous studies have suggested that insulin might improve weight and
pulmonalry function in CF patients with diabetes. In daily practice we often
see CF patients with clinical deterioration 4-5 years before the diagnosis
CF-related diabetes. We feel these patients already have hyperglycaemic events
more often, resulting in pulmonary infections and declined pulmonary function.
We hypothesize that low-dose long-acting insulin will improve nutritional
status in CF patients without diabetes.
Study objective
To investigate the effect of low-dose long acting insulin therapy on
nutritional status in adult CF patients without diabetes.
Study design
A prospective randomized double-blind placebo-controlled trial.
Intervention
All patients will be randomized for either insulin or placebo.
Study burden and risks
The study period will be 26 weeks for each patient, including 2 weeks run-in
period and 24 weeks of therapy. During this period patients will visit the
hospital at least 5 times. At each visit patients are seen under fasting
conditions in order to give blood and patients will be interviewed and examined
physically. During the treatment period patients have to inject themselves
subcutaneously, once a day with insulin/placebo. We ask patients to keep up a
diary with bloodglucose levels, insulin dosage and intake. Before and after the
study period pulmonary function will be measured and patients have to answer a
validated quality of life questionnaire for CF patients.
Leyweg 275
2545 CH Den Haag
NL
Leyweg 275
2545 CH Den Haag
NL
Listed location countries
Age
Inclusion criteria
Patients aged 18 years diagnosed with cystic fibrosis, a normal or impaired glucose tolerance test, exocrine pancreatic insufficiency, BMI <21.
Exclusion criteria
pregnancy, pregnancy wish, lactation, history of organ transplantation, high urgency status on waiting list for transplantation, use of systemic corticosteroids within one month before or 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, BMI >30.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-001916-69-NL |
| CCMO | NL36694.098.12 |