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

NCT ID: NCT04012736

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-13
• Study Completion Date: 2022-04-05

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.

Conditions

Celiac Disease in Children

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Celiac disease

Celiac disease subjects enrolled after diagnosis and before gluten free diet initiation

No interventions assigned to this group

Control

Healthy controls with no chronic condition

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

eyal zifman

Head of Pediatric Gastroenterology Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eyal Zifman, MD

Role: PRINCIPAL_INVESTIGATOR

Meur Medical Center, Kfar-Saba, Israel

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

Other Identifiers

MMC059-19CTIL

Identifier Type: -

Identifier Source: org_study_id