Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00763412|
Recruitment Status : Completed
First Posted : October 1, 2008
Results First Posted : June 5, 2017
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Related Diabetes Pancreatic Insufficiency||Drug: placebo Drug: repaglinide||Not Applicable|
As people with Cystic Fibrosis (CF) are living well into adulthood new complications are arising. CF-Related Diabetes (CFRD) has emerged as a major complication. Years prior to the diagnosis of CFRD, patients have decreasing insulin secretion, glucose intolerance, deteriorating pulmonary function, and nutritional impairment. There are no current standard recommendations for the treatment of CF patients with prediabetes, and there is little evidence that treatment of this prediabetic state in CF patients will prevent the deterioration of the lung function, nutritional status and potentially slow the progression to manifest CFRD.
To determine the feasibility of testing this hypothesis, we will perform a pilot, double-blinded, randomized controlled trial in 20 CF pancreatic insufficient patients ages of 12 to 24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) and assign them to either placebo or Repaglinide 0.5 mg PO 3 - 4 times a day before meals for two years. Patients will monitor their blood glucose daily and will be followed every 3 months for 2 years to determine changes in nutritional status by BMI and DEXA, lung function tests, frequency of hospitalizations, antibiotic courses, and degree of glucose tolerance, insulin secretion and insulin sensitivity.
In addition, based on the evidence of increased inflammation in type 2 diabetes, correlation of systemic inflammatory response at different degrees of glucose tolerance and after treatment, will be assessed in these subjects, as well as in another 20 CF pancreatic insufficient matched patients with normal glucose tolerance who will be studied once without intervention
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Placebo Comparator: 1 Placebo
1 pill before each meal 3-4 times a day for 2 years. All subjects had abnormal glucose tolerance. Subjects were randomized to placebo or drug.
CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
Experimental: 2. repaglinide
repaglinide 0.5 mg before each meal 3-4 times a day for 2 years. All subjects had abnormal glucose tolerance.Subjects were randomized to placebo or drug.
CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
Other Name: Prandin
- BMI [ Time Frame: 2 year/end of study ]
- Body Composition [ Time Frame: 2 year/end of study ]Reporting % of Fat and Lean body mass
- CRP [ Time Frame: 2 year/end of study ]
- Glucose Tolerance [ Time Frame: 2-year ]We completed the OGTT at the 2 year/end of study visit.
- Inflammatory Markers [ Time Frame: 2 year/end of study ]
- Wt Z Score [ Time Frame: 2 year/end of study ]
- Tanner Stage [ Time Frame: 2 year/end of study ]Puberty scale measuring 1-5, 1 being least development, 5 being most development.
- FEV 1 [ Time Frame: 2 year/end of study ]% of lung function
- C-Peptide [ Time Frame: 2 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763412
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Study Chair:||Neil H White, M.D.||Washington University School of Medicine|