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AzTrials

Cystic FibrosisNCT00287443

Metabolic Abnormalities in Hispanic Children With Cystic Fibrosis

A study testing Oral Glucose tolerance test, Whole body protein turnover and IV glucose tolerance test in people with Cystic Fibrosis, run by University of Texas Southwestern Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 7 to 17 years
Conditions the study is for
Cystic Fibrosis
What is being tested?
Oral Glucose tolerance test, Whole body protein turnover and IV glucose tolerance test
How many people
0 participants
Where
1 siteUnited States
Study dates
2 Feb 2006to 2 Feb 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Medical Center of Dallas

    Dallas, Texas, 75390

Other trials in United States

About this study

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.
Read the 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.

Conditions
Cystic Fibrosis
Being tested
Oral Glucose tolerance test, Whole body protein turnover, IV glucose tolerance test, Indirect Calorimetry, Dual Energy X-ray Absorptiometry (DEXA)
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral Glucose tolerance testProcedure or surgery

  • Whole body protein turnoverProcedure or surgery

  • IV glucose tolerance testProcedure or surgery

  • Indirect CalorimetryProcedure or surgery

  • Dual Energy X-ray Absorptiometry (DEXA)Procedure or surgery

  • Growth Hormone Stimulation TestProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2006 (estimated)
  2. Study start2 Feb 2006 (estimated)
  3. Primary completion2 Feb 2006 (estimated)
  4. Study completion2 Feb 2006

Why it stopped: PI no longer with the University

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00287443
Sponsor's protocol ID
0303-161
Status last verified
Dec 2018
First submitted
2 Feb 2006
Last updated
26 Dec 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Oral Glucose tolerance test, Whole body protein turnover and IV glucose tolerance test in people with Cystic Fibrosis, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.

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