Clinical trial NCT01129232: Diabetes Virus Detection Project, Intervention With GAD-alum
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes, Type I
Enterovirus Infections
Autoimmunity
Keywords: insulin
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
timeFrame: 18 months after inclusion
measure: Prevalence of virus infected islets in pancreatic biopsies
timeFrame: 18 months after inclusion
measure: Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
timeFrame: 2 weeks after inclusion
measure: Prevalence of virus infected islets in pancreatic biopsies
timeFrame: 2 weeks after inclusion
Secondary outcomes:
measure: Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test
timeFrame: 36 months after diagnosis
measure: Insulin dosage/kilo bodyweight/24 hours
timeFrame: 36 months after diagnosis
measure: Glycosylated hemoglobin A1 (HbA1c)
timeFrame: 36 months after diagnosis
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker
Study officials:
affiliation: Oslo University Hospital
name: Knut Dahl-Jorgensen, Prof
role: PRINCIPAL_INVESTIGATOR
References: