Insulin therapy to improve BMI in cystic fibrosis-related diabetes without fasting hyperglycemia: results of the cystic fibrosis related diabetes therapy trial.
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.


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-.
Moran
Antoinette
A
University of Minnesota, Minneapolis, Minnesota, USA. moran001@umn.edu
Pekow
Penelope
P
Grover
Patricia
P
Zorn
Martha
M
Slovis
Bonnie
B
Pilewski
Joseph
J
Tullis
Elizabeth
E
Liou
Theodore G
TG
Allen
Holley
H
D000328:Adult; D015992:Body Mass Index; D003550:Cystic Fibrosis / Q000150:complications*; D003920:Diabetes Mellitus / Q000188:drug therapy* / Q000209:etiology*; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000150:complications*; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male
D007004:Hypoglycemic Agents; D007328:Insulin