Carbohydrate Counting and DASH Intervention Among Children With Diabetes and Celiac Disease.

Not Applicable

• Conditions: Celiac Disease in Children; Diabetes Mellitus, Type 1

• Registration Number: NCT05132725
• Lead Sponsor: University of Jordan

Brief Summary

Study is an interventional clinical trial. children (aged 6-18 years) diagnosed with type 1 diabetes and celiac disease will be recruited conveniently from Endocrinology pediatric clinic at Prince Hamzah Hospital. Amman, Jordan. A sample of 45 diagnosed children, who will meet the inclusion criteria and will be agreed to participate will be centrally randomized to follow carbohydrate counting with GFD dietary intervention, carbohydrate counting with GFD and DASH dietary intervention, and control dietary intervention.

Detailed Description

the main objective of this study to compare the effects of three diets: carbohydrate count with gluten-free diet, DASH and carbohydrate count with gluten-free diet, and gluten-free diet alone on glycemic control, growth rate, and the quality of life of 45 individual patients diagnosed with diabetes and celiac disease, who are receiving care in Prince Hamzah Hospital, and aged between 6-18 years, will be enrolled in this study. the duration of the follow-up will be up to ( 9 months); starting from the first interview and enrollment till reaching 9 months from the intervention. all the biochemical tests that are routinely measured will be recorded for each patients during the follow-up duration. these biochemical tests will be, mainly hemoglobin A1C, serum glucose, tissue-trans glutamines IgA( TTG IgA), vitamin D, calcium, phosphorus, and acute intermittent porphyria ( AIP) and will be recorded at baseline, after 6 months and at the end of the study (12 months). growth rate, and quality of life will be also assessed at based line, after 6 months and at the end of the study.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-13
• Study First Submitted QC: 2021-11-13
• Last Update Submitted: 2021-11-13
• Study Start: 2021-11-15
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24
• Primary Completion: 2022-06-15
• Study Completion: 2022-11-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1- Jordanian children aged between 6 to 18 years old . 2- diagnosed with diabetes type 1 and celiac disease together. -

Exclusion Criteria

1- any children diagnosed with celiac disease alone. 2- any children diagnosed with type 1 diabetes alone. 3- any children with different disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
glucose serum	one year	fasting blood glucose% at both baseline and endline of intervention.
HbA1c	one year	Hemoglobin A1c% at both baseline and endline of intervention
TTG-IgA	one year	TTG-IgA% \\ at both and endline of intervention.

Secondary Outcome Measures

Name	Time	Method
Weekly weight gain	one year	weight in kilogram will be measured every 3 months for all participants.
height	one year	height will be measured every 3 months for participants.
BMI	one year	body mass index will be measured according to the weight and height.

Trial Locations

Locations (1)

Marah Al Majali; 🇯🇴 Amman, Jordan