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Body Composition and Hormonal Status in Ataxia Telangiectasia

NCT02345200 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2015-01-26

No results posted yet for this study

Summary

Ataxia telangiectasia (A-T) is a rare devastating human recessive disorder characterized by progressive cerebellar ataxia, immunodeficiency, chromosomal instability, and cancer susceptibility. In addition to that, a high percentage of patients show dystrophy, growth retardation and poor weight gain. Nevertheless, there are only a few studies assessing this problem. Aim of the present proposal is to investigate the exact body composition, manual muscle strength and hormonal status in patients with A-T compared to healthy controls matched for gender and age. A pelvic sonography in females was performed in order to evaluate the sexual maturity of their inner genitalia. Tanner score was determined to define the physical development. Every subject received a nutritional diary to review its calorie intake and the quality of diet. The investigators expect that the A-T cohort shows an altered body composition, impaired muscle strength, changed hormonal status concerning the sexual hormones and a delayed physical development compared to healthy controls.

Conditions

  • Ataxia Telangiectasia

Interventions

PROCEDURE

bioelectrical impedance analysis

electrophysical measurement that allows to determine the exact composition of single body compartments by producing a magnetic field and detecting the potential difference through the body

PROCEDURE

blood draw

blood samples are taken at 8 am in order to pay attention to the circadian rhythmicity to get a detailed hormonal status

Sponsors & Collaborators

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Principal Investigators

  • Stefan Zielen, Prof. Dr. · University Childrens´ Hospital Frankfurt

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-04-30
Completion
2014-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02345200 on ClinicalTrials.gov