Insulin Therapy to Improve BMI in Cystic Fibrosis–Related Diabetes Without Fasting Hyperglycemia
Results of the Cystic Fibrosis Related Diabetes Therapy Trial
Antoinette Moran , MD 1 ,
Penelope Pekow , PHD 2 ,
Patricia Grover , RN 1 ,
Martha Zorn , MS 2 ,
Bonnie Slovis , MD 3 ,
Joseph Pilewski , MD 4 ,
Elizabeth Tullis , MD 5 ,
Theodore G. Liou , MD 6 ,
Holley Allen , MD 7 and
the Cystic Fibrosis Related Diabetes Therapy Study Group *
1 University of Minnesota, Minneapolis, Minnesota;
2 University of Massachusetts, Amherst, Massachusetts;
3 Vanderbilt University, Nashville, Tennessee;
4 University of Pittsburgh, Pittsburgh, Pennsylvania;
5 St. Michael's Hospital, Toronto, Ontario, Canada;
6 University of Utah, Salt Lake City, Utah;
7 Baystate Medical Center, Springfield, Massachusetts.
Corresponding author: Antoinette Moran, moran001{at}umn.edu .
Abstract
OBJECTIVE Cystic fibrosis–related diabetes (CFRD) without fasting hyperglycemia (CFRD FH−) is not associated with microvascular or
macrovascular complications, leading to controversy about the need for treatment. The Cystic Fibrosis Related Diabetes Therapy
(CFRDT) Trial sought to determine whether diabetes therapy improves BMI in these patients.
RESEARCH DESIGN AND METHODS A three-arm multicenter randomized trial compared 1 year of therapy with premeal insulin aspart, repaglinide, or oral placebo
in subjects with cystic fibrosis who had abnormal glucose tolerance.
RESULTS One hundred adult patients were enrolled. Eighty-one completed the study, including 61 with CFRD FH− and 20 with severly
impaired glucose tolerance (IGT). During the year before therapy, BMI declined in all groups. Among the group with CFRD FH−,
insulin-treated patients lost 0.30 ± 0.21 BMI units the year before therapy. After 1 year of insulin therapy, this pattern
reversed, and they gained 0.39 ± 21 BMI units ( P = 0.02). No significant change in the rate of BMI decline was seen in placebo-treated patients ( P = 0.45). Repaglinide-treated patients had an initial significant BMI gain (0.53 ± 0.19 BMI units, P = 0.01), but this effect was not sustained. After 6 months of therapy they lost weight so that by 12 months there was no
difference in the rate of BMI change during the study year compared with the year before ( P = 0.33). Among patients with IGT, neither insulin nor repaglinide affected the rate of BMI decline. No significant differences
were seen in the rate of lung function decline or the number of hospitalizations in any group.
CONCLUSIONS Insulin therapy safely reversed chronic weight loss in patients with CFRD FH−.
Footnotes
↵ *A complete list of the Cystic Fibrosis Related Diabetes Therapy Study Group can be found in the online appendix at http://care.diabetesjournals.org/cgi/content/full/dc09-0585/DC1 .
Clinical trial reg. no. NCT00072904, clinicaltrials.gov .
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore
be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
Received March 25, 2009.
Accepted June 24,...

Insulin Therapy to Improve BMI in Cystic Fibrosis–Related Diabetes Without Fasting Hyperglycemia

10.2337/dc09-0585