A Phase 2 interventional study of GAD-alum and Placebo in Diabetes, Type I, Enterovirus Infections and Autoimmunity, sponsored by Oslo University Hospital. Terminated at 1 site in Norway. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-05-17.
Sponsored by Oslo University Hospital · Phase 2, Interventional, and Treatment
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.
47 studies on the registry are indexed under Enterovirus Infections; 5 are open to participants now.
This study's enrollment of 6 is below the median of 150 across 31 interventional studies indexed under Enterovirus Infections.
Browse Enterovirus Infections studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
GAD-alum administered at 0 and 1 months after inclusion
Drug: GAD-alum
Other: Placebo
20 µg of GAD-alum injected sc after the biopsy, and repeated after one month
Also known as: Diamyd
Placebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm)
Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
Time frame: 18 months after inclusion
Prevalence of virus infected islets in pancreatic biopsies
Time frame: 18 months after inclusion
Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
Time frame: 2 weeks after inclusion
Prevalence of virus infected islets in pancreatic biopsies
Time frame: 2 weeks after inclusion
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
Time frame: 36 months after diagnosis
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
Time frame: 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
Time frame: 36 months after diagnosis
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oslo University Hospital