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

Sponsor

Meir Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04012736

Collaborator

(none)

100

Enrollment

Location

38.6

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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:

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 Design

Study Type:

Observational

Anticipated 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

Actual Study Start Date :

Aug 13, 2019

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Flamingo balance test [6 months]
Flamingo balance test recorded in times in 60sec (n).
Sit and reach test [6 months]
Sit and reach test recorded in cm.
Standing broad jump test [6 months]
Standing broad jump test recorded in cm.
Handgrip test [6 months]
Handgrip test recorded kg.
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

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.
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.
Body mass index [6 months]
Weight and height will be combined to report BMI in kg/m^2
Total body fat [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 [6 months]
Bone speed of sound in m/s. Measured with a bone sonometer (Sunlight Omnisense, Somerset, NJ, USA).

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meir Medical Center	Kfar Saba		Israel	4464402

Sponsors and Collaborators

Meir Medical Center

Investigators

Principal Investigator: Eyal Zifman, MD, Meur Medical Center, Kfar-Saba, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

eyal zifman, Head of Pediatric Gastroenterology Service, Meir Medical Center

ClinicalTrials.gov Identifier:

NCT04012736

Other Study ID Numbers:

MMC059-19CTIL

First Posted:

Jul 9, 2019

Last Update Posted:

Sep 3, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by eyal zifman, Head of Pediatric Gastroenterology Service, Meir Medical Center

gluten free diet

fitness

pediatric

Additional relevant MeSH terms:

Celiac Disease

Study Results

No Results Posted as of Sep 3, 2020