An interventional study of diet therapy in Diabetes Mellitus, Type 1 and Celiac Disease in Children, sponsored by University of Jordan. Status unknown at 1 site in Jordan. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-11-24.
Sponsored by University of Jordan · Not applicable, Interventional, and Treatment
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.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's planned enrollment of 45 is close to the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →University of Jordan is the lead sponsor of 126 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Carbohydrate counting diet will be prepared according to Kulkarni, (2005). Tailored diet plans according to patient's food preference, physical activity level and appropriate insulin: Carbohydrates ratio will be prescribed for each participants. Diets were based on each participants' recommended intakes of energy, protein (15-25%), fat (30-40%) and carbohydrate (40-50%) (Thomas and Gutierrez, 2005; Kleinwechter et al., 2014). Energy requirement will be determined in the participants' weight. The carbohydrate counts will be distributed into three main meals and 3 snacks, with the general dietary advice and diet that will be prescribed by hospital for participants
Behavioral: diet therapy
The recommended intakes of energy, protein (15-25%), fat (30-40%) and carbohydrate (40-50%) will be similar to that in carbohydrate counting diet which mentioned above. DASH diet food choices will be inserted in the diet of the participants assigned for the combined diet of DASH and carbohydrate counting. The emphasis will be more on the fruits and vegetables group (\>8 servings/day), whole grains (at least half of the amount of the total servings of cereals; 6-8 servings/day), fat free dairy products (2-3 servings/day), lean meat and plant proteins (0-2 servings/day) and nuts (5-7 servings/week). From the fat group olive oil will represent the main type of fat (20-25% of total fat %). Adequate intake of sodium (2000mg) will be applied into participants' diet, with the general dietary advice and diet that will be prescribed by hospital for participants
Behavioral: diet therapy
the general dietary advice and diet that will be prescribed by hospital for participants
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.
HbA1c
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
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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University of Jordan