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TEFA Family Prevention: Glutenfree Diet to Preserve Beta-cell Function

NCT02605148 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-10-26

No results posted yet for this study

Summary

To evaluate the effect of Gluten Free Diet (GFD) on beta-cell function and glucose metabolism in subjects with one or several islet autoantibodies without and with dysglycemia at baseline. Additionally, all subjects will be given treatment with Vitamin D, omega fatty acids and probiotics.

Subjects will be randomized to GFD or normal diet during 18 months. Beta cell function will be evaluated at baseline, and during follow-up by glucose tolerance tests.

Conditions

Interventions

DIETARY_SUPPLEMENT

Gluten free diet

Gluten free diet during 18 months.

DIETARY_SUPPLEMENT

Omega 3 fatty acid

Omega 3 fatty acid

DIETARY_SUPPLEMENT

Vitamin D

Vitamin D 800 U/day

DIETARY_SUPPLEMENT

Probiotics

Probiotics

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Lund University

    lead OTHER

Principal Investigators

  • Maria Månsson Martinez, Nutricionist · Lund University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02605148 on ClinicalTrials.gov