treatment with insulin in patients with cystic fibrosis without diabetes

insulin therapy in non-diabetic adults with cystic fibrosis - insulin in CF without CFRD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001916-69-NL

Enrollment

Registered

2012-02-07

Start date

2012-05-22

Completion date

Unknown

Last updated

2013-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cystic fibrosis patients without cystic fibrosis related diabetes

Interventions

Trade Name: Lantus 100 units/ml solution for injection in a cartridge Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Countries

Netherlands

Contacts

Public Contactmicrobiologist, Hagaziekenhuis

Dhr. R. Brimicombe

r.brimicombe@hagaziekenhuis.nl+310702100000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026