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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 November 2021
• Main ID: NCT02605148
• Date of registration: 11/11/2015
• Prospective Registration: Yes
• Primary sponsor: Lund University
• Public title: TEFA Family Prevention: Glutenfree Diet to Preserve Beta-cell Function TEFA
• Scientific title: TEFA TEDDY Family Prevention - Gluten Free Diet to Preserve Beta-cell Function in Subjects With Islet Autoimmunity.
• Date of first enrolment: December 2015
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02605148
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Maria Månsson Martinez, Nutricionist
• Affiliation: Lund University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects from two (2) to 49,99 years of age.

2. At least one type 1 diabetes-associated autoantibody (to glutamic acid (GADA), insulin
(IAA), insulinoma-associated protein 2 (IA-2A) or zinktransporter 8 (ZnT8R/W/QA) in
subjects with impaired glucose metabolism OR at least two type 1 diabetes-associated
autoantibodies, regardless of normal or impaired glucose metabolism.

3. Written informed consent from research subject. If a child, also from the child's
parents or legal acceptable representative(s) according to local regulations.

Exclusion Criteria:

1. Ongoing treatment with immunosuppressant therapy (topical or inhaled steroids are
accepted).

2. Diabetes.

3. Treatment with any oral or injected anti-diabetic medications.

4. Significantly abnormal hematology results at screening.

5. Participation in other clinical trials with a new chemical entity within the previous
3 months.

6. History of hypercalcemia.

7. Presence of associated serious disease or condition.

8. Diabetes-protective HLA-DQ6-allele.

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Age minimum: 2 Years
Age maximum: 49 Years
Gender: All

Health Condition(s) or Problem(s) studied

Prediabetes

Type 1 Diabetes

Intervention(s)

Dietary Supplement: Omega 3 fatty acid

Dietary Supplement: Vitamin D

Dietary Supplement: Gluten free diet

Dietary Supplement: Probiotics

Primary Outcome(s)

Change in glucose metabolism [Time Frame: 24 months]

Change in first phase insulin response (FPIR) from IvGTT [Time Frame: 24 months]

Change in area under the curve (AUC) C-peptide [Time Frame: 24 months]

Secondary Outcome(s)

Incidence of Treatment-Emergent Adverse Events [Time Frame: 24 months]

Secondary ID(s)

TEFA/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Juvenile Diabetes Research Foundation