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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6
Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker
Oslo, Norway
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.