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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132725
• Other study ID #: UJordanM
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: November 11, 2022

Study information

• Verified date: November 2021
• Source: University of Jordan
• Contact: marah AT al-majali, master
• Phone: +962797571009
• Email: marahmajali93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 11, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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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Related Conditions & MeSH terms

• Celiac Disease
• Celiac Disease in Children
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
Jordan	Marah Al Majali	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

References & Publications (8)

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. Review. — View 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. — View 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. Epub 2005 Nov 15. Review. — View Citation

Björck 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. — View 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. — View 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. — View Citation

Dydensborg Sander S, Hansen AV, Størdal 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Hemoglobin A1c% at both baseline and endline of intervention	one year
Primary	glucose serum	fasting blood glucose% at both baseline and endline of intervention.	one year
Primary	TTG-IgA	TTG-IgA% \ at both and endline of intervention.	one year
Secondary	Weekly weight gain	weight in kilogram will be measured every 3 months for all participants.	one year
Secondary	height	height will be measured every 3 months for participants.	one year
Secondary	BMI	body mass index will be measured according to the weight and height.	one year