Diabetes Therapy to Improve BMI and Lung Function in CF

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)108 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Cystic Fibrosis Diabetes Mellitus

Interventions

Insulin AsparteDRUG

Insulin asparte given 0.5 units per carb per meal

RepaglinideDRUG

0.5mg tab with meals tid

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

* 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

Locations (7)

Stanford University

Palo Alto, California, United States

Baystate Medical Center

Springfield, Massachusetts, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Time frame: 12 months

Data from ClinicalTrials.gov

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