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

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ClinicalTrials.gov Identifier: NCT04012736
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
eyal zifman, 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.

Condition or disease
Celiac Disease in Children

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Physical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Celiac disease
Celiac disease subjects enrolled after diagnosis and before gluten free diet initiation
Control
Healthy controls with no chronic condition



Primary Outcome Measures :
  1. Flamingo balance test [ Time Frame: 6 months ]
    Flamingo balance test recorded in times in 60sec (n).

  2. Sit and reach test [ Time Frame: 6 months ]
    Sit and reach test recorded in cm.

  3. Standing broad jump test [ Time Frame: 6 months ]
    Standing broad jump test recorded in cm.

  4. Handgrip test [ Time Frame: 6 months ]
    Handgrip test recorded kg.

  5. Sit-ups test [ Time Frame: 6 months ]
    Sit-ups test is recorded in times in 30sec (n).

  6. Bent arm hang test [ Time Frame: 6 months ]
    Bent arm hang test recorded in sec.

  7. Twenty meter endurance shuttle run test [ Time Frame: 6 months ]
    Twenty meter endurance shuttle run test recorded in times (n).


Secondary Outcome Measures :
  1. Weight [ Time Frame: 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.

  2. Height [ Time Frame: 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.

  3. Body mass index [ Time Frame: 6 months ]
    Weight and height will be combined to report BMI in kg/m^2

  4. Total body fat [ Time Frame: 6 months ]
    Total body fat in percents. Measured with a body composition scale (model MC-780U, Tanita, Arlington Heights, IL, USA).

  5. Bone speed of sound [ Time Frame: 6 months ]
    Bone speed of sound in m/s. Measured with a bone sonometer (Sunlight Omnisense, Somerset, NJ, USA).



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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. 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.

Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012736


Contacts
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Contact: Eyal Zifman, MD +972545740004 eyalzi@clalit.org.il

Locations
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Israel
Meir Medical Center Not yet recruiting
Kfar Saba, Israel, 4464402
Contact: Eyal Zifman, MD    +972545740004    eyalzi@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Eyal Zifman, MD Meur Medical Center, Kfar-Saba, Israel

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Responsible Party: eyal zifman, Head of Pediatric Gastroenterology Service, Meir Medical Center
ClinicalTrials.gov Identifier: NCT04012736     History of Changes
Other Study ID Numbers: MMC059-19CTIL
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by eyal zifman, Meir Medical Center:
gluten free diet
fitness
pediatric

Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases