NCT02605148

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Lund University · Academic / Other
• Sex: All
• Age: 2 Years – 49 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prediabetes
• Type 1 Diabetes

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	Probiotics	Probiotics

Timeline

• Start date: 2015-12-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2015-11-16
• Last updated: 2021-10-26

Locations

1 site across 1 country: Sweden