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

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: Children's Hospitals and Clinics of Minnesota
• Treatments: Insulin; Insulin Aspart; Insulin Detemir; Insulin, Globin Zinc; Insulin, Short-Acting

Criteria

Inclusion Criteria:

1. Diagnosis of cystic fibrosis, age 10-25 years

2. A standard routine annual OGTT performed within 12 months of randomization

3. 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).

Exclusion Criteria:

1. Diagnosis of CFRD, Consensus Conference definition (45)

2. Previous organ transplant, or transplant imminent during study period

3. BMI percentile >95

4. Treatment with systemic glucocorticoids (nasal or inhaled glucocorticoids are acceptable)

5. Therapy with growth hormone or Megace

6. Nighttime continuous drip gastrostomy/jejunostomy feedings

7. Pregnancy or breast-feeding or plans to become pregnant during study period

8. 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.

9. Any anticipated change in medication during the 3 month study period

10. Acute illness in the 6 weeks prior to enrollment