TEFA Family Prevention: Glutenfree Diet to Preserve Beta-cell Function
NCT ID: NCT02605148
Last Updated: 2021-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-12-31
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Gluten free diet
Gluten free diet during 18 months.
Omega 3 fatty acid
Omega 3 fatty acid
Vitamin D
Vitamin D 800 U/day
Probiotics
Probiotics
Normal diet
Normal diet. Vitamin D 800 U Daily, Omega 3 fatty acids and probiotics as nutritional supplements.
Omega 3 fatty acid
Omega 3 fatty acid
Vitamin D
Vitamin D 800 U/day
Probiotics
Probiotics
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gluten free diet
Gluten free diet during 18 months.
Omega 3 fatty acid
Omega 3 fatty acid
Vitamin D
Vitamin D 800 U/day
Probiotics
Probiotics
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
\-
2 Years
49 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Juvenile Diabetes Research Foundation
OTHER
Lund University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maria Månsson Martinez
Study coordinator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria Månsson Martinez, Nutricionist
Role: PRINCIPAL_INVESTIGATOR
Lund University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lund University, Department of Clinical Sciences Malmö
Malmo, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TEFA/2015
Identifier Type: -
Identifier Source: org_study_id