Physical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet

Terminated

• Conditions: Celiac Disease in Children

• Registration Number: NCT04012736
• Lead Sponsor: Meir Medical Center

Brief Summary

Evaluating the effect of Celiac disease (CD) and gluten free diet (GFD) on physical fitness parameters among CD subjects. The CD subjects will be compared to healthy controls.

Detailed Description

This is a prospective observational cohort study. The study would take place at Meir Medical Center (Kfar-Saba, Israel), a secondary-level academic hospital. The investigators will enroll 50 newly diagnosed CD subjects. The diagnosis will be in accordance with the European Society for Gastroenterology Hepatology and Nutrition guidelines for the diagnosis of CD from 2012 (6). The investigators will also enroll 50 control subjects. The control subjects are children visiting the pediatric gastroenterology clinic. Before enrollment the investigators will rule out chronic conditions involving the gastrointestinal tract including CD.

All subjects will be enrolled after providing an informed consent and signing the consent form.

The investigators will obtain the following measurements and evaluations at and 6 months after enrollment:

1. Anthropometric measurements: Height, weight, body mass index (BMI) and total body fat will be evaluated using a TANITA scale. The z-score for each parameter will be recorded.

2. A Godin leisure-time exercise questionnaire (7) will be filled by the subjects and their parents

3. Evaluation of physical fitness by the Eurofit fitness testing (8). This series of physical fitness tests was developed to evaluate speed, stamina and strength in school-aged children.

1. Flamingo balance test

2. Seat and reach test

3. Standing broad jump test

4. Handgrip test

5. Sit-ups test

6. Bent arm hang test

7. Twenty meter endurance shuttle run test

8. Wingate anaerobic fitness test

4. Bone speed of sound test will be performed by a bone sonometer - a non-invasive ultrasound based measurement of bone density.

5. CD subjects will be evaluated for adherence to GFD via questioning by a pediatric gastroenterologist and a clinical dietitian and by serum tissue transglutaminase immunoglobulin A (IgA) level (or serum deamidated gliadin peptide immunoglobulin G level in IgA deficient subjects). This is part of the normal follow-up of CD patients.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-07-07
• Study First Posted: 2019-07-09
• Study Start: 2019-08-13
• Primary Completion: 2022-04-05
• Study Completion: 2022-04-05
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

1. Children aged 4-18y visiting the pediatric gastroenterology clinic
2. Signing a consent form

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Exclusion Criteria

1. Family history of cardiovascular diseases or sudden death before age 50y
2. Chronic condition limiting the ability to perform the physical fitness tests (e.g. juvenile idiopathic arthritis)
3. Failure to complete the measurements and evaluations by 2 months from the date of the visit at the clinic

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sit and reach test	6 months	Sit and reach test recorded in cm.
Handgrip test	6 months	Handgrip test recorded kg.
Flamingo balance test	6 months	Flamingo balance test recorded in times in 60sec (n).
Standing broad jump test	6 months	Standing broad jump test recorded in cm.
Sit-ups test	6 months	Sit-ups test is recorded in times in 30sec (n).
Bent arm hang test	6 months	Bent arm hang test recorded in sec.
Twenty meter endurance shuttle run test	6 months	Twenty meter endurance shuttle run test recorded in times (n).

Secondary Outcome Measures

Name	Time	Method
Weight	6 months	Weight in kilograms. Measured with an electronic scale (model 500KL, Health o meter, McCook, IL, USA). Range 0-220kg, rounded to the nearest 0.1kg.
Body mass index	6 months	Weight and height will be combined to report BMI in kg/m\^2
Height	6 months	Height in centimeters. Measured with a wall-mounted stadiometer (model 240, Seca, Hamburg, Germany). Range 0-240cm, rounded to the nearest 0.1cm.
Bone speed of sound	6 months	Bone speed of sound in m/s. Measured with a bone sonometer (Sunlight Omnisense, Somerset, NJ, USA).
Total body fat	6 months	Total body fat in percents. Measured with a body composition scale (model MC-780U, Tanita, Arlington Heights, IL, USA).

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel