To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).

Condition	Treatment or Intervention	Phase
Cystic Fibrosis Diabetes Mellitus	Drug: Insulin Aspart  Drug: Rapaglinide	Phase III

Further Study Details: 

Expected Total Enrollment:  150

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.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Trish Grover, RN      612-624-0135    grove026@umn.edu

California
      Stanford University, Palo Alto,  California,  94304,  United States; Recruiting
Massachusetts
      Baystate Medical Center, Springfield,  Massachusetts,  01199,  United States; Recruiting
Minnesota
      University of Minnesota Medical Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Pennsylvania
      Children's Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15213-2583,  United States; Recruiting
Tennessee
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232-2650,  United States; Recruiting
Utah
      University of Utah, Salt Lake City,  Utah,  84132-4701,  United States; Recruiting
Canada, Ontario
      St. Michael's Hospital, Toronto,  Ontario,  M5B 1W8,  Canada; Recruiting

Study ID Numbers:  58356DK
Record last reviewed:  February 2005
Last Updated:  February 7, 2005
Record first received:  November 12, 2003
ClinicalTrials.gov Identifier:  NCT00072904
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08