search
Back to results

Diabetes Therapy to Improve BMI and Lung Function in CF

Primary Purpose

Cystic Fibrosis, Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Insulin Asparte
Repaglinide
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis Related Diabetes, Diabetes without Fasting Hyperglycemia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University
  • Baystate Medical Center
  • University of Minnesota Medical Center
  • Children's Hospital of Pittsburgh
  • Vanderbilt University Medical Center
  • University of Utah
  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

III

Arm Description

Placebo take half tab with meals tid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 12, 2003
Last Updated
February 27, 2012
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Cystic Fibrosis Foundation, Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT00072904
Brief Title
Diabetes Therapy to Improve BMI and Lung Function in CF
Official Title
Diabetes Therapy to Improve BMI and Lung Function in CF
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Cystic Fibrosis Foundation, Novo Nordisk A/S

4. Oversight

5. Study Description

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 insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).
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 function in cystic fibrosis patients who have diabetes without fasting hyperglycemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Diabetes Mellitus
Keywords
Cystic Fibrosis Related Diabetes, Diabetes without Fasting Hyperglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
III
Arm Type
Placebo Comparator
Arm Description
Placebo take half tab with meals tid
Intervention Type
Drug
Intervention Name(s)
Insulin Asparte
Intervention Description
Insulin asparte given 0.5 units per carb per meal
Intervention Type
Drug
Intervention Name(s)
Repaglinide
Intervention Description
0.5mg tab with meals tid
Primary Outcome Measure Information:
Title
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoinette Moran, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2583
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2650
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-4701
Country
United States
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19592632
Citation
Moran A, Pekow P, Grover P, Zorn M, Slovis B, Pilewski J, Tullis E, Liou TG, Allen H; Cystic Fibrosis Related Diabetes Therapy Study Group. Insulin therapy to improve BMI in cystic fibrosis-related diabetes without fasting hyperglycemia: results of the cystic fibrosis related diabetes therapy trial. Diabetes Care. 2009 Oct;32(10):1783-8. doi: 10.2337/dc09-0585. Epub 2009 Jul 10.
Results Reference
result

Learn more about this trial

Diabetes Therapy to Improve BMI and Lung Function in CF

We'll reach out to this number within 24 hrs