Metabolic Abnormalities in Hispanic Children With Cystic Fibrosis

December 21, 2018 updated by: University of Texas Southwestern Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

We will recruit 12 Hispanic prepubertal children with CF (ages 7-12, Tanner I) and 12 Hispanic adolescents (ages 15-17, Tanner 3 or 4) from the CF Centers at University of Texas Southwestern and Baylor College of Medicine in Houston. Information obtained from these subjects will be compared to 12 prepubertal and 12 adolescent Caucasian children with CF recruited from the same CF centers. We will categorize the subjects according to glucose tolerance (OGTT), as well as insulin secretion and insulin sensitivity using the IVGTT and the Minimal Model, as modified for children. We will also compare the historical information of socio-economic status and family history. Clinical status will be characterized by measuring pulmonary function and modified NIH scores, in addition to measuring levels of circulating cytokines. Gluconeogenesis (GNG) will be quantified by measuring the incorporation 2H into the 2nd, 5th and 6th carbons of glucose. Whole body protein turnover (WBPT) will be measured using [1-13C]leucine. Nutritional status will be determined by three-day food journals, and intake will be compared to energy needs, utilizing indirect calorimetry to measure resting energy expenditure. Subjects will be recruited from the CF centers at the University of Texas- Southwestern and the South Central CF Consortium.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Children's Medical Center of Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Subjects will be required to be medically stable at the time of the study. Medical stability will be defined as:

  1. No hospital admission for six weeks or more before the study
  2. No oral or intravenous antibiotics for at least six weeks preceding the study (subjects will be allowed to use low doses of inhaled corticosteroids)
  3. Weight-stable (weight deviation less than 2.5 kilograms) for two months prior to the study.

Exclusion Criteria:

  1. Use of oral or intravenous corticosteroid medications within six weeks of the study
  2. Evidence of severe liver disease (hepatomegaly, 30% or greater elevation of liver transaminases, listed for liver transplant)
  3. Colonization with Burkholderia cepacia
  4. Pregnancy
  5. Patients requiring supplemental oxygen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Dana s HArdin, University of Texas, Southwestern Medical Center at Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 2, 2006

Primary Completion (Anticipated)

February 2, 2006

Study Completion (Actual)

February 2, 2006

Study Registration Dates

First Submitted

February 2, 2006

First Submitted That Met QC Criteria

February 2, 2006

First Posted (Estimate)

February 6, 2006

Study Record Updates

Last Update Posted (Actual)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 21, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0303-161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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