Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis Related Diabetes; Pancreatic Insufficiency
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Diabetes Mellitus; Prediabetic State; Glucose Intolerance; Fibrosis
Study type: Interventional

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.
    

Detailed description: 
      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
    

Intervention name(s): placebo; repaglinide
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Prandin
Intervention MeSH terms: Repaglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Cystic Fibrosis; Diabetes; Cystic Fibrosis Related Diabetes; Pre-diabetes; oral hypoglycemic agents; Repaglinide; treatment; inflammatory markers; Lung function; nutrition