Clinical trial NCT04012736: Physical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet
Official title: Physical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Celiac Disease in Children
Keywords: gluten free diet
fitness
pediatric
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 3
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Flamingo balance test
timeFrame: 6 months
measure: Sit and reach test
timeFrame: 6 months
measure: Standing broad jump test
timeFrame: 6 months
measure: Handgrip test
timeFrame: 6 months
measure: Sit-ups test
timeFrame: 6 months
measure: Bent arm hang test
timeFrame: 6 months
measure: Twenty meter endurance shuttle run test
timeFrame: 6 months
Secondary outcomes:
measure: Weight
timeFrame: 6 months
measure: Height
timeFrame: 6 months
measure: Body mass index
timeFrame: 6 months
measure: Total body fat
timeFrame: 6 months
measure: Bone speed of sound
timeFrame: 6 months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meur Medical Center, Kfar-Saba, Israel
name: Eyal Zifman, MD
role: PRINCIPAL_INVESTIGATOR
References: