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

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ClinicalTrials.gov Identifier: NCT05132725
Recruitment Status : Recruiting
First Posted : November 24, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Marah Al Majali, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Celiac Disease in Children Behavioral: diet therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : November 15, 2021
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : November 11, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dietary intervention CHO counting combined with GFD
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
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.

Experimental: Dietary intervention CHO Counting with GFD & DASH
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
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.

No Intervention: General Dietary guidlines
the general dietary advice and diet that will be prescribed by hospital for participants



Primary Outcome Measures :
  1. HbA1c [ Time Frame: one year ]
    Hemoglobin A1c% at both baseline and endline of intervention

  2. glucose serum [ Time Frame: one year ]
    fasting blood glucose% at both baseline and endline of intervention.

  3. TTG-IgA [ Time Frame: one year ]
    TTG-IgA% \ at both and endline of intervention.


Secondary Outcome Measures :
  1. Weekly weight gain [ Time Frame: one year ]
    weight in kilogram will be measured every 3 months for all participants.

  2. height [ Time Frame: one year ]
    height will be measured every 3 months for participants.

  3. BMI [ Time Frame: one year ]
    body mass index will be measured according to the weight and height.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05132725


Contacts
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Contact: marah AT al-majali, master +962797571009 marahmajali93@gmail.com
Contact: reema tayyem, PHD r_tayyem@yahoo.com

Locations
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Jordan
Marah Al Majali Recruiting
Amman, Jordan
Contact: marah al majali, MSc    +962797571009    marahmajali93@gmail.com   
Sponsors and Collaborators
University of Jordan
Investigators
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Principal Investigator: marah AT al-majali, master student
Study Director: reema tayyem, phd supervisor
Publications:

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Responsible Party: Marah Al Majali, student, University of Jordan
ClinicalTrials.gov Identifier: NCT05132725    
Other Study ID Numbers: UJordanM
First Posted: November 24, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Celiac Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases