N/A
N=16
Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
Cystic Fibrosis Related Diabetes · Pancreatic Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00763412 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: BMI — 19.63; 21.19 Kg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- placebo (Drug); repaglinide (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Arbelaez, Ana Maria
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BMI |
19.63; 21.19 | — |
| PRIMARY Body Composition |
19.82; 26.21; 77.15; 70.83 | — |
| PRIMARY CRP |
9.6; 2 | — |
| SECONDARY Glucose Tolerance |
101.5; 94.5; 185.75; 184 | — |
| SECONDARY Inflammatory Markers |
0.14; 0.34; 10.4; 6; 5.8; 5.2 | — |
| SECONDARY Wt Z Score |
-1.21; -0.26 | — |
| SECONDARY Tanner Stage |
4.25; 5 | — |
| SECONDARY FEV 1 |
90.5; 91.5 | — |
| SECONDARY C-Peptide |
1.5; 1.6; 7.5; 7.7 | — |
Summary
The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
Eligibility Criteria
Inclusion Criteria
- Male or females 12 -24 years old
- Diagnosis of Cystic Fibrosis by sweat test with exocrine pancreatic insufficiency
- Must have a glucose pattern by Oral Glucose Tolerance Test with fasting blood glucose 200 mg/dl.
- Weight must be stable within 5% for 3 months prior to initiation visit
- Must be able to reproducibly perform spirometry based on American Thoracic Society guidelines
Exclusion Criteria
- Patients receiving growth hormone therapy or taking insulin
- Patients with evidence of liver dysfunction
- Patients who are status-post lung or liver transplantation
- Patients who have received systemic steroids for more than 28 days during the 6 months prior to the study
- Patients with active ABPA on steroids
- Patients taking medications that affect glucose metabolism or contraindicated with repaglinide
Data sourced from ClinicalTrials.gov (NCT00763412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.