NCT00287443

Metabolic Abnormalities in Hispanic Children With Cystic Fibrosis

Withdrawn NA Last updated 26 December 2018

What this trial tests

NA trial testing Oral Glucose tolerance test in Cystic Fibrosis. Withdrawn.

Timeline

2 February 2006

Primary endpoint
2 February 2006

2 February 2006

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Start date	2 February 2006
Primary completion	2 February 2006
Estimated completion	2 February 2006
Sites	1 location across United States

Drugs / interventions tested

• Oral Glucose tolerance test — full drug profile →
• Whole body protein turnover
• IV glucose tolerance test
• Indirect Calorimetry
• Dual Energy X-ray Absorptiometry (DEXA)
• Growth Hormone Stimulation Test

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 7 to 17, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Our specific aims include:

1. AIM 1. Characterization of glucose tolerance, nutritional and clinical status, socioeconomic status, family history of diabetes and genotype in Hispanic CF children compared to Caucasian CF children. Each child will undergo a two-hour oral glucose tolerance test and will be categorized by glucose tolerance according to standards set forth by the 1998 CF Consensus Conference on Diabetes. Nutritional status will be determined by three-day food journals and intake will be compared to energy needs measured by indirect calorimetry. Socio-economic status will be calculated from reported family income and medical insurance coverage. Genotyping will be done at the laboratory of Dr. Arthur Beaudet at Baylor College of Medicine. Clinical status will be measured using modified NIH scores. Family history for both type 1 and type 2 diabetes will be obtained in Spanish by Dr.Vanderwel. This specific aim tests the hypothesis that glucose intolerance /frank CF related diabetes occurs at a younger age in Hispanics than in Caucasians with CF, and is correlated to family history of diabetes and clinical status.
2. AIM 2. Characterization of insulin secretion and insulin sensitivity. Previous studies in adults have described peripheral insulin resistance as a major cause of CF related diabetes, yet studies have not been conducted in children. Studies in adults and children without CF suggest that insulin resistance occurs more frequently in Hispanics. We will measure insulin secretion and insulin sensitivity using the frequently sampled intravenous glucose tolerance test (IVGTT) and the minimal model analysis of Bergman, as modified for children. This specific aim tests the hypothesis that Hispanic children with CF have worse peripheral insulin resistance, but similar insulin secretion when compared to Caucasian children with CF.
3. AIM 3. Quantification of post-absorptive gluconeogenesis and whole body protein turnover. Total hepatic glucose production (HGP) will be measured using \[6,6-2H2\]glucose. We will quantify gluconeogenesis by measurement of the incorporation of 2H into the 2nd, 5th and 6th carbons of glucose following 2H20 administration method of Landau). We will determine whole body protein turnover using the stable isotopes \[1-13C\]leucine and will measure serum amino acid levels. This specific aim tests the hypothesis that gluconeogenesis and whole body protein turnover are disproportionately higher in Hispanic children and adolescents with CF than in Caucasian CF children.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.