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

October 18, 2021 updated by: Maria Månsson Martinez, Lund University

TEFA TEDDY Family Prevention - Gluten Free Diet to Preserve Beta-cell Function in Subjects With Islet Autoimmunity.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The design is a randomized controlled study to determine the safety and the effect of gluten free diet during 18 months on beta-cell function and glucose metabolism. Lead-in and nonstop supplement cocktail including vitamin D, omega fatty acids and probiotics will be used to equalize differences to reduce known confounders. All study subjects will meet with a dietician to obtain a 3-day diet record and to receive instructions on a healthy normal diet or GFD.

Subjects (n=60) at 2-49.99 years of age positive for one or several islet autoantibodies will be recruited. Subjects with one islet autoantibody have done one or several oral glucose tolerance test (OGTT) prior to the baseline visit. One islet autoantibody positive subjects are only eligible if they have dysglycemia. All subjects will be randomized based on baseline intravenous glucose tolerance test (IvGTT) and OGTT into subjects without and with dysglycemia at baseline.

Beta-cell function and glucose metabolism (alternating IvGTT and OGTT) will be assessed at baseline and after 6, 12, 18 months of treatment and after 6 months of wash out on a normal healthy diet.

Adverse events and safety Adverse event will be obtained at visits and during the study, which will be monitored.

It is expected that subjects with one or several islet autoantibodies will show a loss compared to baseline of beta-cell function and glucose control. GFD is expected to reduce the loss in subjects on a healthy diet.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, 20502
        • Lund University, Department of Clinical Sciences Malmö

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gluten free diet
Gluten free diet during 18 months. The subjects will be referred to a nutritionist every 6 months. Vitamin D 800 U Daily, Omega 3 fatty acids and probiotics as nutritional supplements.
Dietary supplement: Probiotics
Probiotics
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
Active Comparator: Normal diet
Normal diet. Vitamin D 800 U Daily, Omega 3 fatty acids and probiotics as nutritional supplements.
Dietary supplement: Probiotics
Probiotics
Dietary supplement: Omega 3 fatty acid
Omega 3 fatty acid
Dietary supplement: Vitamin D
Vitamin D 800 U/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in first phase insulin response (FPIR) from IvGTT
Time Frame: 24 months
Change in First phase insulin response from IvGTT during follow-up
24 months
Change in area under the curve (AUC) C-peptide
Time Frame: 24 months
Change in AUC C-peptide from OGTT during follow-up
24 months
Change in glucose metabolism
Time Frame: 24 months
Change from normal to impaired glucose metabolism during follow-up
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 24 months
To evaluate safety of GFD compared to recommended normal diet in the placebo group in subjects supplemented with lead in and nonstop treatment with a cocktail including vitamin D, omega fatty acids and probiotics.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Juvenile Diabetes Research Foundation

Investigators

  • Principal Investigator: Maria Månsson Martinez, Nutricionist, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 13, 2015

First Posted (Estimate)

November 16, 2015

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEFA/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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