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

NCT ID: NCT05132725

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2022-11-11

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1 Celiac Disease in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

diet therapy

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

diet therapy

Intervention Type BEHAVIORAL

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.

General Dietary guidlines

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Marah Al Majali

student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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marah AT al-majali, master

Role: PRINCIPAL_INVESTIGATOR

student

reema tayyem, phd

Role: STUDY_DIRECTOR

supervisor

Locations

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Marah Al Majali

Amman, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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marah AT al-majali, master

Role: CONTACT

Phone: +962797571009

Email: [email protected]

reema tayyem, PHD

Role: CONTACT

Email: [email protected]

Facility Contacts

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marah al majali, MSc

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 18162844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18413210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16287899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28319607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30238885 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28210247 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29593435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30045024 (View on PubMed)

Other Identifiers

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UJordanM

Identifier Type: -

Identifier Source: org_study_id