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

Primary Purpose

Diabetes Mellitus, Type 1, Celiac Disease in Children

Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
diet therapy
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

-

Sites / Locations

  • Marah Al MajaliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Dietary intervention CHO counting combined with GFD

Dietary intervention CHO Counting with GFD & DASH

General Dietary guidlines

Arm Description

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

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

the general dietary advice and diet that will be prescribed by hospital for participants

Outcomes

Primary Outcome Measures

HbA1c
Hemoglobin A1c% at both baseline and endline of intervention
glucose serum
fasting blood glucose% at both baseline and endline of intervention.
TTG-IgA
TTG-IgA% \ at both and endline of intervention.

Secondary Outcome Measures

Weekly weight gain
weight in kilogram will be measured every 3 months for all participants.
height
height will be measured every 3 months for participants.
BMI
body mass index will be measured according to the weight and height.

Full Information

First Posted
November 13, 2021
Last Updated
November 13, 2021
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT05132725
Brief Title
Carbohydrate Counting and DASH Intervention Among Children With Diabetes and Celiac Disease.
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Anticipated)
Primary Completion Date
June 15, 2022 (Anticipated)
Study Completion Date
November 11, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Celiac Disease in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietary intervention CHO counting combined with GFD
Arm Type
Experimental
Arm Description
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
Arm Title
Dietary intervention CHO Counting with GFD & DASH
Arm Type
Experimental
Arm Description
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
Arm Title
General Dietary guidlines
Arm Type
No Intervention
Arm Description
the general dietary advice and diet that will be prescribed by hospital for participants
Intervention Type
Behavioral
Intervention Name(s)
diet therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c
Description
Hemoglobin A1c% at both baseline and endline of intervention
Time Frame
one year
Title
glucose serum
Description
fasting blood glucose% at both baseline and endline of intervention.
Time Frame
one year
Title
TTG-IgA
Description
TTG-IgA% \ at both and endline of intervention.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Weekly weight gain
Description
weight in kilogram will be measured every 3 months for all participants.
Time Frame
one year
Title
height
Description
height will be measured every 3 months for participants.
Time Frame
one year
Title
BMI
Description
body mass index will be measured according to the weight and height.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marah AT al-majali, master
Phone
+962797571009
Email
marahmajali93@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
reema tayyem, PHD
Email
r_tayyem@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marah AT al-majali, master
Organizational Affiliation
student
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
reema tayyem, phd
Organizational Affiliation
supervisor
Official's Role
Study Director
Facility Information:
Facility Name
Marah Al Majali
City
Amman
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
marah al majali, MSc
Phone
+962797571009
Email
marahmajali93@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
18162844
Citation
Agostoni C, Decsi T, Fewtrell M, Goulet O, Kolacek S, Koletzko B, Michaelsen KF, Moreno L, Puntis J, Rigo J, Shamir R, Szajewska H, Turck D, van Goudoever J; ESPGHAN Committee on Nutrition:. Complementary feeding: a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2008 Jan;46(1):99-110. doi: 10.1097/01.mpg.0000304464.60788.bd.
Results Reference
background
PubMed Identifier
18413210
Citation
Ajlouni K, Khader YS, Batieha A, Ajlouni H, El-Khateeb M. An increase in prevalence of diabetes mellitus in Jordan over 10 years. J Diabetes Complications. 2008 Sep-Oct;22(5):317-24. doi: 10.1016/j.jdiacomp.2007.01.004. Epub 2008 Apr 16.
Results Reference
background
PubMed Identifier
16287899
Citation
Akobeng AK, Ramanan AV, Buchan I, Heller RF. Effect of breast feeding on risk of coeliac disease: a systematic review and meta-analysis of observational studies. Arch Dis Child. 2006 Jan;91(1):39-43. doi: 10.1136/adc.2005.082016. Epub 2005 Nov 15.
Results Reference
background
PubMed Identifier
28319607
Citation
Bjorck S, Brundin C, Karlsson M, Agardh D. Reduced Bone Mineral Density in Children With Screening-detected Celiac Disease. J Pediatr Gastroenterol Nutr. 2017 Nov;65(5):526-532. doi: 10.1097/MPG.0000000000001568.
Results Reference
background
PubMed Identifier
30238885
Citation
Caio G, De Giorgio R, Volta U. Coeliac disease and dermatitis herpetiformis. Lancet. 2018 Sep 15;392(10151):916-917. doi: 10.1016/S0140-6736(18)31486-7. No abstract available.
Results Reference
background
PubMed Identifier
28210247
Citation
Chander AM, Nair RG, Kaur G, Kochhar R, Dhawan DK, Bhadada SK, Mayilraj S. Genome Insight and Comparative Pathogenomic Analysis of Nesterenkonia jeotgali Strain CD08_7 Isolated from Duodenal Mucosa of Celiac Disease Patient. Front Microbiol. 2017 Feb 2;8:129. doi: 10.3389/fmicb.2017.00129. eCollection 2017.
Results Reference
background
PubMed Identifier
29593435
Citation
Dydensborg Sander S, Hansen AV, Stordal K, Andersen AN, Murray JA, Husby S. Mode of delivery is not associated with celiac disease. Clin Epidemiol. 2018 Mar 19;10:323-332. doi: 10.2147/CLEP.S152168. eCollection 2018.
Results Reference
background
PubMed Identifier
30045024
Citation
Kaur N, Bhadada SK, Minz RW, Dayal D, Kochhar R. Interplay between Type 1 Diabetes Mellitus and Celiac Disease: Implications in Treatment. Dig Dis. 2018;36(6):399-408. doi: 10.1159/000488670. Epub 2018 Jul 25.
Results Reference
background

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

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