Status:
COMPLETED
Diabetes Therapy to Improve BMI and Lung Function in CF
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
Cystic Fibrosis Foundation
Novo Nordisk A/S
Conditions:
Cystic Fibrosis
Diabetes Mellitus
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 functi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00072904
Start Date
June 1 2001
End Date
December 1 2007
Last Update
February 28 2012
Active Locations (7)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
3
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
4
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2583