Diabetes Therapy to Improve BMI and Lung Function in CF

• ClinicalTrials.gov Identifier: NCT00072904
• Recruitment Status: Completed
• First Posted: November 14, 2003
• Last Update Posted: February 28, 2012
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborators: Cystic Fibrosis Foundation; Novo Nordisk A/S
• Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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).

Condition or disease	Intervention/treatment	Phase
Cystic Fibrosis; Diabetes Mellitus	Drug: Insulin Asparte; Drug: Repaglinide	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Diabetes Therapy to Improve BMI and Lung Function in CF
• Study Start Date: June 2001
• Actual Primary Completion Date: December 2007
• Actual Study Completion Date: December 2007

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: III; Placebo take half tab with meals tid	Drug: Insulin Asparte; Insulin asparte given 0.5 units per carb per meal; Drug: Repaglinide; 0.5mg tab with meals tid

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

Stanford University

Palo Alto, California, United States, 94304

United States, Massachusetts

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

United States, Minnesota

University of Minnesota Medical Center

Minneapolis, Minnesota, United States, 55455

United States, Pennsylvania

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213-2583

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232-2650

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84132-4701

Canada, Ontario

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Sponsors and Collaborators

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

Cystic Fibrosis Foundation

Novo Nordisk A/S

Investigators

• Principal Investigator: Antoinette Moran, MD; University of Minnesota

More Information

Publications of Results:

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.

• Responsible Party: Antoinette Moran, University Of Minnesota
• ClinicalTrials.gov Identifier: NCT00072904
• Obsolete Identifiers: NCT00177151
• Other Study ID Numbers: 58356DK (completed)
• First Posted: November 14, 2003
• Last Update Posted: February 28, 2012
• Last Verified: February 2012

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Cystic Fibrosis Related Diabetes; Diabetes without Fasting Hyperglycemia

Additional relevant MeSH terms:

Cystic Fibrosis; Fibrosis; Repaglinide; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Hypoglycemic Agents; Physiological Effects of Drugs