Diabetes Therapy to Improve BMI and Lung Function in CF - Full Text View

Purpose

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	Intervention	Phase
Cystic Fibrosis Diabetes Mellitus	Drug: Insulin Asparte Drug: Repaglinide	Phase III

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Cystic Fibrosis Diabetes

ChemIDplus related topics:

Insulin AG-EE 388 ZW

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Diabetes Therapy to Improve BMI and Lung Function in CF

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	108
Study Start Date:	June 2001
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
III: Placebo Comparator 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

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072904

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

Investigators


Principal Investigator:	Antoinette Moran, MD	University of Minnesota

More Information

Responsible Party:	University Of Minnesota ( Antoinette Moran )
Study ID Numbers:	58356DK
First Received:	November 12, 2003
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00072904
Health Authority:	United States: Food and Drug Administration

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

Cystic Fibrosis Related Diabetes

Diabetes without Fasting Hyperglycemia

Study placed in the following topic categories:

Metabolic Diseases

Fibrosis

Diabetes Mellitus

Endocrine System Diseases

Insulin

Repaglinide

Hyperglycemia

Digestive System Diseases

Cystic Fibrosis

Respiratory Tract Diseases

Genetic Diseases, Inborn

Lung Diseases

Pancreatic Diseases

Infant, Newborn, Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Cystic fibrosis

Additional relevant MeSH terms:

Hypoglycemic Agents

Pathologic Processes

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Cystic Fibrosis Foundation Novo Nordisk
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00072904