Diabetes Therapy to Improve BMI and Lung Function in CF
Insulin Asparte
+ Repaglinide
Cystic Fibrosis+10
+ Diabetes Mellitus
+ Digestive System Diseases
Treatment Study
Summary
Study start date: June 1, 2001
Actual date on which the first participant was enrolled.The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes without fasting hyperglycemia.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.108 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
* Diabetic glucose pattern by oral glucose tolerance test (OGTT) of \>200 at 120 min. (stable and healthy at time of OGTT) * Fasting glucose levels \<126. * Weight stable within 5% in previous 3 months. * Free from illness for two months. * Male and female 16 and older, who are done growing * Willing to come in for visits every 3 months. * Patients receiving infrequent short bursts of systemic glucocorticoids may be considered for the study inclusion if: a. they have not received systemic glucocorticoids steroids for at least one month, b. they did not receive the steroids for more than 14 consecutive days or 28 days total in six months
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
100% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Baystate Medical Center
Springfield, United StatesUniversity of Minnesota Medical Center
Minneapolis, United StatesChildren's Hospital of Pittsburgh
Pittsburgh, United States