The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

Insulin replacement therapy may be effective in breaking the cycle of protein catabolism, undernutrition and overall clinical deterioration in pre-diabetic, insulin insufficient CF youth because of its potent anabolic effect. A significant number of CF patients might benefit from this therapeutic approach with a substantial impact on morbidity and mortality.

Key facts

Study ID

NCT02496780

Run by

University of Minnesota

People needed

65

Starts

2015-08-01

Expected to finish

2022-07-01

Last updated by the study team

2025-03-17

Who can join

Age: 10 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of cystic fibrosis, age 10-25 years
• A standard routine annual OGTT performed within 12 months of randomization
• Abnormal glucose tolerance, with a fasting glucose level <126 mg/dl and
• The 1-hr OGTT glucose is ≥200 mg/dl but the 2-hr glucose is <140 (INDET), OR
• The 2-hour OGTT glucose is 140-199 mg/dl (impaired glucose tolerance, IGT).

You may not qualify if…

• Diagnosis of CFRD, Consensus Conference definition (45)
• Previous organ transplant, or transplant imminent during study period
• BMI percentile >95
• Treatment with systemic glucocorticoids (nasal or inhaled glucocorticoids are acceptable)
• Therapy with growth hormone or Megace
• Nighttime continuous drip gastrostomy/jejunostomy feedings
• Pregnancy or breast-feeding or plans to become pregnant during study period
• Any change in medications during the 3 months prior to the study
• Exception: the new corrector/potentiator combination drug lumacaftor/ivacaftor is expected to get FDA approval in early 2015, and most CF patients with severe genotypes, including many eligible for this proposal, will receive this drug. This is not a contraindication to participation in the current proposal (and participation in other studies is not contraindicated in the PROSPECT post-marketing drug study). Though the primary effects of the combination therapy appear to be apparent after 1 month, we will wait 6 months after initiation of lumacaftor/ivacaftor before enrollment in this study to make sure subjects are in a steady state.
• Any anticipated change in medication during the 3 month study period
• Acute illness in the 6 weeks prior to enrollment

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States
• Children's Hospitals and Clinics of Minnesota — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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