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

Further Study Details: 

Expected Total Enrollment:  39

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.

Ages Eligible for Study:  18 Years   -   30 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

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

Study chairs or principal investigators

Dana S. Hardin,  Study Chair,  Southwest Medical Center at Dallas   

Study ID Numbers:  199/15802; UUSOM-R03DK5660401; UUSOM-IRB-7835-00
Record last reviewed:  January 2005
Last Updated:  January 21, 2005
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014781
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08