- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02496780
The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
Saint Paul, Minnesota, United States
- Children's Hospitals and Clinics of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
once or 3x daily injectable placebo (insulin diluent)
|
once or 3x daily
Other Names:
|
Experimental: basal insulin levemir
once daily basal insulin therapy with insulin levemir
|
basal insulin once a day
Other Names:
|
Experimental: rapid-acting insulin Novolog
pre-meal rapid-acting insulin 3x/day with insulin novolog
|
3x daily rapid-acting insulin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post-prandial protein turnover
Time Frame: 5 hour meal study
|
triple tracer of phenylalanine meal study, results reported as rate of appearance and disappearance of phenylalanine during a 5 hour meal study at baseline and after 1 month of insulin or placebo therapy
|
5 hour meal study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Antoinette Moran, MD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Endocrine System Diseases
- Infant, Newborn, Diseases
- Diabetes Mellitus
- Genetic Diseases, Inborn
- Pancreatic Diseases
- Fibrosis
- Prediabetic State
- Cystic Fibrosis
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin Detemir
Other Study ID Numbers
- PEDS-2015-23490
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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