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

NCT02605148 | Unknown

• 1 other identifier: TEFA/2015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Prediabetes; Type 1 Diabetes

Keywords

Islet autoimmunity; gluten free diet; prediabetes; prevention; type 1 diabetes; glucose tolerance test

Outcome Measures

Primary Outcomes (3)

• Change in first phase insulin response (FPIR) from IvGTT

  Change in First phase insulin response from IvGTT during follow-up

  24 months

• Change in area under the curve (AUC) C-peptide

  Change in AUC C-peptide from OGTT during follow-up

  24 months

• Change in glucose metabolism

  Change from normal to impaired glucose metabolism during follow-up

  24 months

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  24 months

Study Arms (2)

Gluten free diet

EXPERIMENTAL

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: Gluten free diet; Dietary Supplement: Omega 3 fatty acid; Dietary Supplement: Vitamin D; Dietary Supplement: Probiotics

Normal diet

ACTIVE COMPARATOR

Normal diet. Vitamin D 800 U Daily, Omega 3 fatty acids and probiotics as nutritional supplements.

Dietary Supplement: Omega 3 fatty acid; Dietary Supplement: Vitamin D; Dietary Supplement: Probiotics

Interventions

Gluten free diet DIETARY_SUPPLEMENT

Gluten free diet during 18 months.

Gluten free diet

Omega 3 fatty acid DIETARY_SUPPLEMENT

Omega 3 fatty acid

Gluten free diet; Normal diet

Vitamin D DIETARY_SUPPLEMENT

Vitamin D 800 U/day

Gluten free diet; Normal diet

Probiotics DIETARY_SUPPLEMENT

Probiotics

Gluten free diet; Normal diet

Eligibility Criteria

• Age: 2 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects from two (2) to 49,99 years of age.
• 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.
• Written informed consent from research subject. If a child, also from the child's parents or legal acceptable representative(s) according to local regulations.

You may not qualify if:

• Ongoing treatment with immunosuppressant therapy (topical or inhaled steroids are accepted).
• Diabetes.
• Treatment with any oral or injected anti-diabetic medications.
• Significantly abnormal hematology results at screening.
• Participation in other clinical trials with a new chemical entity within the previous 3 months.
• History of hypercalcemia.
• Presence of associated serious disease or condition.
• Diabetes-protective HLA-DQ6-allele.

Sponsors & Collaborators

• Lund University: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Lund University, Department of Clinical Sciences Malmö

Malmo, 20502, Sweden

Location

Related Publications (2)

• Martinez MM, Spiliopoulos L, Salami F, Agardh D, Toppari J, Lernmark A, Kero J, Veijola R, Tossavainen P, Palmu S, Lundgren M, Borg H, Katsarou A, Larsson HE, Knip M, Maziarz M, Torn C; and the TEDDY-Family (TEFA) Study Group. Heterogeneity of beta-cell function in subjects with multiple islet autoantibodies in the TEDDY family prevention study - TEFA. Clin Diabetes Endocrinol. 2022 Jan 5;7(1):23. doi: 10.1186/s40842-021-00135-6.

  PMID: 34983671 DERIVED

• Martinez MM, Salami F, Larsson HE, Toppari J, Lernmark A, Kero J, Veijola R, Koskenniemi JJ, Tossavainen P, Lundgren M, Borg H, Katsarou A, Maziarz M, Torn C; TEDDY Family (TEFA) Study Group. Beta cell function in participants with single or multiple islet autoantibodies at baseline in the TEDDY Family Prevention Study: TEFA. Endocrinol Diabetes Metab. 2020 Nov 5;4(2):e00198. doi: 10.1002/edm2.198. eCollection 2021 Apr.

  PMID: 33855205 DERIVED

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 1

Interventions

Diet, Gluten-Free; Fatty Acids, Omega-3; Vitamin D; Probiotics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dietary Supplements; Food; Food and Beverages

Study Officials

• Maria Månsson Martinez, Nutricionist

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 16, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)