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
|Condition or disease|
|Celiac Disease in Children|
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:
- 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.
- A Godin leisure-time exercise questionnaire (7) will be filled by the subjects and their parents
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.
- Flamingo balance test
- Seat and reach test
- Standing broad jump test
- Handgrip test
- Sit-ups test
- Bent arm hang test
- Twenty meter endurance shuttle run test
- Wingate anaerobic fitness test
- Bone speed of sound test will be performed by a bone sonometer - a non-invasive ultrasound based measurement of bone density.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
Celiac disease subjects enrolled after diagnosis and before gluten free diet initiation
Healthy controls with no chronic condition
- Flamingo balance test [ Time Frame: 6 months ]Flamingo balance test recorded in times in 60sec (n).
- Sit and reach test [ Time Frame: 6 months ]Sit and reach test recorded in cm.
- Standing broad jump test [ Time Frame: 6 months ]Standing broad jump test recorded in cm.
- Handgrip test [ Time Frame: 6 months ]Handgrip test recorded kg.
- Sit-ups test [ Time Frame: 6 months ]Sit-ups test is recorded in times in 30sec (n).
- Bent arm hang test [ Time Frame: 6 months ]Bent arm hang test recorded in sec.
- Twenty meter endurance shuttle run test [ Time Frame: 6 months ]Twenty meter endurance shuttle run test recorded in times (n).
- 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.
- 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.
- Body mass index [ Time Frame: 6 months ]Weight and height will be combined to report BMI in kg/m^2
- 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).
- 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).
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
|Contact: Eyal Zifman, MDemail@example.com|
|Meir Medical Center||Not yet recruiting|
|Kfar Saba, Israel, 4464402|
|Contact: Eyal Zifman, MD +972545740004 firstname.lastname@example.org|
|Principal Investigator:||Eyal Zifman, MD||Meur Medical Center, Kfar-Saba, Israel|