Studying the Effect of Gluten Free Diet Alone Versus Combination of Gluten Free Diet With Either Carbohydrate Count or Dietary Approach to Reduce Hypertension Diet on Their Glycemic Control, Growth Rate and Quality of Life Among Children With Type 1 Diabetes Mellitus and Celiac Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- University of Jordan
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- HbA1c
- Last Updated
- 4 years ago
Overview
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.
Investigators
Marah Al Majali
student
University of Jordan
Eligibility Criteria
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.
Outcomes
Primary Outcomes
HbA1c
Time Frame: one year
Hemoglobin A1c% at both baseline and endline of intervention
glucose serum
Time Frame: one year
fasting blood glucose% at both baseline and endline of intervention.
TTG-IgA
Time Frame: one year
TTG-IgA% \\ at both and endline of intervention.
Secondary Outcomes
- Weekly weight gain(one year)
- height(one year)
- BMI(one year)