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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002027-82 | EudraCT Number |
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Complications to procedure
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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).
The aetiology of type 1 diabetes is unknown. Both genetic and environmental factors seem to be important for the destruction of insulin producing beta cells in the pancreas. Increasing indirect evidences exist that picornaviruses may either directly or indirectly through autoimmune processes destroy beta cells. New sensitive assays have been developed to detect these viruses and to study the immunological processes, especially T-cell function. Microsurgical technology has been refined, now making pancreatic biopsies a safe procedure. This study focuses on advanced in depth studies of immunology and virology in pancreatic tissue and small intestine at an early stage of disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GAD-alum | Experimental | GAD-alum administered at 0 and 1 months after inclusion |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GAD-alum | Drug | 20 µg of GAD-alum injected sc after the biopsy, and repeated after one month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies | 18 months after inclusion | |
| Prevalence of virus infected islets in pancreatic biopsies | 18 months after inclusion | |
| Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies | 2 weeks after inclusion | |
| Prevalence of virus infected islets in pancreatic biopsies | 2 weeks after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Insulin dosage/kilo bodyweight/24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Knut Dahl-Jorgensen, Prof | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker | Oslo | 0514 | Norway |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D004769 | Enterovirus Infections |
| D001327 | Autoimmune Diseases |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Other | Placebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm) |
|
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 |
| 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 |
| D004700 | Endocrine System Diseases |
| D007154 | Immune System Diseases |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D006946 | Hyperinsulinism |