Study of Hepatic Glucose Production and De Novo Lipogenesis in Patients With Cystic Fibrosis - Full Text View

Sponsor:	University of Utah
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00014781

Purpose

OBJECTIVES:

I. Determine the amount of hepatic glucose production derived from gluconeogenesis and glycogenolysis in the post-absorptive state in patients with cystic fibrosis.

II. Determine de novo lipogenesis in relationship to resting energy expenditure in this patient population.

Condition
Cystic Fibrosis

Study Type:

Observational

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	39
Study Start Date:	February 2001

Detailed Description:

PROTOCOL OUTLINE:

Patients undergo an oral glucose tolerance test (OGTT) in which blood is drawn from an IV in the arm 6 times over 3 hours. After the first blood draw, patients receive a beverage containing sugar and write down everything they ate and drank during the 24 hours before study entry. Patients also undergo a dual energy x-ray absorptiometry (DEXA) scan over 15 minutes.

Within 2 weeks after the OGTT, patients keep a journal of everything they ate and drank over 3 days. Patients are fed a selected meal the following evening and receive saline fluids IV overnight. During the night, patients receive 2 doses of oral doubly labeled water. The next morning, patients receive [1,2-13C]acetate IV. A liquid mixed meal (Ensure Plus) is ingested hourly throughout the day. Patients also undergo hood indirect calorimetry over 30 minutes twice to measure resting energy expenditure. All urine is collected.

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of cystic fibrosis OR Normal healthy volunteer; not an endurance-trained athlete No colonization with Burkholderia cepacia

--Prior/Concurrent Therapy--

Endocrine therapy: At least 2 months since prior oral or IV corticosteroids; low-dose inhaled corticosteroids allowed

Other: Short-acting insulin therapy allowed; at least 24 hours since prior long-acting insulin (i.e., neutral protamine Hagedorn, or ultalente); at least 4 weeks since prior oral or IV antibiotics; no hospital admissions within the past 6 weeks

--Patient Characteristics--

Hepatic: No elevation of SGOT or SGPT within the past 3 months

Other: Must be medically stable; diabetes mellitus allowed; weight stable within the past 3 months; not pregnant; no prisoners

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014781

Locations

United States, Texas
Southwest Medical Center at Dallas
Dallas, Texas, United States, 75390

Sponsors and Collaborators

University of Utah

Investigators

Study Chair:

Dana S. Hardin

Southwest Medical Center at Dallas

More Information

No publications provided

Study ID Numbers:	199/15802, UUSOM-R03DK5660401, UUSOM-IRB-7835-00
Study First Received:	April 10, 2001
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00014781 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 09, 2009