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Sponsors and Collaborators: |
University of Minnesota Sanofi-Aventis Moran, Antoinette, M.D. |
Information provided by: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00222521 |
This Study is designed to determine whether treatment of CFRD with glargine insulin will improve hemoglobin A1c, weight and muscle mass compared to the traditional regimen of bedtime NPH insulin.
Condition | Intervention | Phase |
Cystic Fibrosis Related Diabetes |
Drug: Glargine insulin |
Phase III |
Genetics Home Reference related topics: | cystic fibrosis |
MedlinePlus related topics: | Cystic Fibrosis Diabetes |
ChemIDplus related topics: | Insulin Insulin glargine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Comparison of Insulin Glargine Vs Standard Insulin Therapy in CFRD Without Fasting Hyperglycemia |
Estimated Enrollment: | 20 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | August 2005 |
The majority of cystic fibrosis (CF) patients now survive beyond childhood, and CF related diabetes (CFRD), due to insulin deficiency, is common. CFRD with fasting hyperglycemia occurs in about 15% of adult CF patients. Standard insulin therapy has relied primarily on meal coverage with rapid-acting insulin. Usually, basal insulin coverage is only provided overnight, with modest doses of NPH insulin. The practice of providing minimal basal insulin in CFRD is based on the fact that most of these patients, unless they are acutely ill, are able to maintain relatively normal blood glucose levels during the day without it. In addition, anecdotal experience has suggested that daytime NPH insulin or once to twice daily ultralente insulin frequently lead to hypoglycemia in the CFRD patient. This practice, which is based on practical clinical considerations, ignores the established relationship between insulin deficiency and clinical deterioration in CFRD. BMI and pulmonary function deteriorate much more rapidly in CF patients with diabetes than in CF patients with normal glucose tolerance. Insulin deficiency leads to increased protein catabolism and fatty acid turnover. The resulting loss of weight and lean body mass contributes to pulmonary disease and clinical decline.
We hypothesize that:
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
CFRD with fasting hyperglycemia (fasting plasma glucose ≥126 mg/dl)
. The diagnosis must be made at a time when the patient is in his/her basal state of health with no evidence of acute exacerbation in the preceding two months.
a). Acute exacerbation is defined on page 9.
Glucocorticoids can have a profound effect on weight, and thus we wish to minimize the occurrence of changing steroid doses during the study period. Patients receiving glucocorticoid therapy will be included in the protocol only if:
Exclusion Criteria
Plans to start any medication in the next 8 months that might affect weight, such as testosterone or Megace. Patients chronically taking these medications may be included if:
United States, Minnesota | |||||
University of Minnesota | |||||
Minneapolis, Minnesota, United States, 55455 |
University of Minnesota |
Sanofi-Aventis |
Moran, Antoinette, M.D. |
Principal Investigator: | Antoinette Moran, MD | University of Minnesota |
Study ID Numbers: | 0205M25461 |
First Received: | September 14, 2005 |
Last Updated: | September 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00222521 |
Health Authority: | United States: Institutional Review Board |
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