Celiac Disease in Children, Diabetes Mellitus, Type 1
Conditions
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.
Interventions
BEHAVIORALdiet therapy
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.
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | one year | Hemoglobin A1c% at both baseline and endline of intervention |
| glucose serum | one year | fasting blood glucose% at both baseline and endline of intervention. |
| TTG-IgA | one year | TTG-IgA% \\ at both and endline of intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Jordan
Contacts
Primary Contactmarah AT al-majali, master
Backup Contactreema tayyem, PHD
Outcome results
None listed