Diabetes Virus Detection Project, Intervention With GAD-alum

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are to test whether GAD vaccination can stop the progression of newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis) in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and finally try to detect viruses and virus receptors directly in the insulin producing beta cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (T1D).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Aluminum sulfate

Criteria

Inclusion Criteria:

• Newly diagnosed classical type-1 diabetes

• Positive GAD antibodies

• Fasting C-peptide >0.1 mmol/l

• Insulin dosage >0.1 U/kg Bodyweight/day

Exclusion Criteria:

• Pregnancy

• Weaning

• Other chronic diseases than diabetes

• Any regular medication except oral contraceptives

• Psychiatric disturbances