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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
Adjusting the quantity and quality of food intake to improve glycemic control, growth rate and quality of life among children with type 1 diabetes and celiac disease.
Marah Al Majali
Amman, Jordan
RECRUITINGHbA1c
Hemoglobin A1c% at both baseline and endline of intervention
Time frame: one year
glucose serum
fasting blood glucose% at both baseline and endline of intervention.
Time frame: one year
TTG-IgA
TTG-IgA% \\ at both and endline of intervention.
Time frame: one year
Weekly weight gain
weight in kilogram will be measured every 3 months for all participants.
Time frame: one year
height
height will be measured every 3 months for participants.
Time frame: one year
BMI
body mass index will be measured according to the weight and height.
Time frame: one year
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