NCT05132725

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2022

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 13, 2021

Last Update Submit

November 13, 2021

Conditions

Diabetes Mellitus, Type 1Celiac Disease in Children

Outcome Measures

Primary Outcomes (3)

  • HbA1c

    Hemoglobin A1c% at both baseline and endline of intervention

    one year

  • glucose serum

    fasting blood glucose% at both baseline and endline of intervention.

    one year

  • TTG-IgA

    TTG-IgA% \\ at both and endline of intervention.

    one year

Secondary Outcomes (3)

  • Weekly weight gain

    one year

  • height

    one year

  • BMI

    one year

Study Arms (3)

Dietary intervention CHO counting combined with GFD

EXPERIMENTAL

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

Dietary intervention CHO Counting with GFD & DASH

EXPERIMENTAL

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

General Dietary guidlines

NO INTERVENTION

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

Interventions

diet therapyBEHAVIORAL

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 & DASHDietary intervention CHO counting combined with GFD

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marah Al Majali

Amman, Jordan

RECRUITING

Related 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. doi: 10.1097/01.mpg.0000304464.60788.bd.

    PMID: 18162844BACKGROUND

  • 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.

    PMID: 18413210BACKGROUND

  • 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.

    PMID: 16287899BACKGROUND

  • 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.

    PMID: 28319607BACKGROUND

  • 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.

    PMID: 30238885BACKGROUND

  • 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.

    PMID: 28210247BACKGROUND

  • 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.

    PMID: 29593435BACKGROUND

  • 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.

    PMID: 30045024BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • marah AT al-majali, master

    student

    PRINCIPAL INVESTIGATOR

  • reema tayyem, phd

    supervisor

    STUDY DIRECTOR

Central Study Contacts

marah AT al-majali, master

CONTACT

+962797571009marahmajali93@gmail.com

reema tayyem, PHD

CONTACT

r_tayyem@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
student

Study Record Dates

First Submitted

November 13, 2021

First Posted

November 24, 2021

Study Start

November 15, 2021

Primary Completion

June 15, 2022

Study Completion

November 11, 2022

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations

JO(1)