Type 1 Diabetes Clinical Trial
— TEFAOfficial title:
TEFA TEDDY Family Prevention - Gluten Free Diet to Preserve Beta-cell Function in Subjects With Islet Autoimmunity.
Verified date | October 2021 |
Source | Lund University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 49 Years |
Eligibility | 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. - |
Country | Name | City | State |
---|---|---|---|
Sweden | Lund University, Department of Clinical Sciences Malmö | Malmö |
Lead Sponsor | Collaborator |
---|---|
Lund University | Juvenile Diabetes Research Foundation |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in first phase insulin response (FPIR) from IvGTT | Change in First phase insulin response from IvGTT during follow-up | 24 months | |
Primary | Change in area under the curve (AUC) C-peptide | Change in AUC C-peptide from OGTT during follow-up | 24 months | |
Primary | Change in glucose metabolism | Change from normal to impaired glucose metabolism during follow-up | 24 months | |
Secondary | Incidence of Treatment-Emergent Adverse Events | 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 |
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