Autoimmunity Clinical Trial
— DiViDOfficial title:
A Phase II-study (Therapeutic Exploratory) of GAD-alum in Newly Diagnosed Type-1 Diabetic Patients, With Focus One the Presence of Viruses at the Time of Diagnosis
Verified date | May 2018 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 6 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies | 18 months after inclusion | ||
Primary | Prevalence of virus infected islets in pancreatic biopsies | 18 months after inclusion | ||
Primary | Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies | 2 weeks after inclusion | ||
Primary | Prevalence of virus infected islets in pancreatic biopsies | 2 weeks after inclusion | ||
Secondary | Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test | Will be measured at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is at 36 months | 36 months after diagnosis | |
Secondary | Insulin dosage/kilo bodyweight/24 hours | Will be calculated at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is 36 months after diagnosis | 36 months after diagnosis | |
Secondary | Glycosylated hemoglobin A1 (HbA1c) | Will be measrured at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is at 36 months. To investigate wether an eventual better endogenous insulin production gives better metabolic control, estimated by lower HbAic | 36 months after diagnosis |
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