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

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014781
• Other study ID #: 199/15802
• Secondary ID: UUSOM-R03DK56604
• Status: Completed
• Phase: N/A
• First received: April 10, 2001
• Last updated: March 10, 2009
• Start date: February 2001

Study information

• Verified date: March 2009
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	Southwest Medical Center at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States,