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Study of Hepatic Glucose Production and De novo Lipogenesis in Patients With Cystic Fibrosis



Study of Hepatic Glucose Production and De novo Lipogenesis in Patients With Cystic Fibrosis

For Condition: Cystic Fibrosis
Status: Recruiting
Sponsor(s): University of Utah ,
Synopsis: 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.
Details: 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:
Study Type:  Observational, Natural History
Minimum Age/Maximum Age: 18 Years/30 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 39

Location and Contact Information:

Overall Study Official:
DanaHardin,  Study Chair,  University of Utah

University of Utah School of Medicine *Recruiting*
Salt Lake City,  Utah,  84132
United States
Recruiting Dana  Hardin 801-585-3485


Additional Information:
Study ID Numbers:  199/15802;  UUSOM-IRB-7835-00,UUSOM-R03DK5660401
Study Start Date: February 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014781

Other Cystic Fibrosis Studies:
1. Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis

2. Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis

3. Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis

4. Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis

5. Phase I Randomized Study of Adeno-Associated Virus-CFTR Vector in Patients with Cystic Fibrosis

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