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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03037190
Date of registration:	26/01/2017
Prospective Registration:	No
Primary sponsor:	Lund University
Public title:	Preservation of Residual Beta Cell Mass and Prevention of Celiac Disease in Children With Recent Onset Type 1 Diabetes Diabglut
Scientific title:	Investigation Whether a Gluten Free Diet After the Onset of Type 1 Diabetes (T1D) Can Better Preserve the Remaining Beta Cell Mass and at the Same Time Prevent the Development of Celiac Disease (CD) in These Patients.
Date of first enrolment:	December 2015
Target sample size:	160
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT03037190
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Sweden

Contacts

Name:	Annelie Carlsson, MD PhD
Address:
Telephone:
Email:
Affiliation:	Lund University

Name:	Annelie Carlsson, MD PhD
Address:
Telephone:	+46768267170
Email:	annelie.carlsson@med.lu.se
Affiliation:

Name:	Annelie Carlsson, MD PhD
Address:
Telephone:	+46768267170
Email:	annelie.carlsson@med.lu.se
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type 1 diabetes according to the ADA classification with < 1 months diabetes duration
at time of screening

- Age 3.00 -17.99 years at time of screening

- Fasting C-peptide at time of screening = 0.12 nmol/L

Exclusion Criteria:

- Inability or unwillingness to comply with the provisions of this protocol

- Deemed by the investigator not being able to follow instructions and/or follow the
study protocol

NB: new ethical approval will be applied for children between 1-3 years of age

Age minimum: 3 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Celiac Disease in Children

Diabetes Mellitus, Type 1

Remission

Intervention(s)

Other: withdrawal of gluten from the diet

Primary Outcome(s)

Preservation of beta cells function [Time Frame: within 2years after the onset of type 1 diabetes]

Secondary Outcome(s)

Prevention of Celiac DIsease [Time Frame: Five years after the onset of Diabetes]

Secondary ID(s)

LUDU

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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