Diabetes Virus Detection Project, Intervention With GAD-alum

Phase 2

Terminated

• Conditions: Autoimmunity; Enterovirus Infections; Diabetes, Type I
• Interventions: Other: Placebo; Drug: GAD-alum

• Registration Number: NCT01129232
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Study Start: 2011-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
GAD-alum	GAD-alum	GAD-alum administered at 0 and 1 months after inclusion

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test	36 months after diagnosis	Will be measured at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is at 36 months
Insulin dosage/kilo bodyweight/24 hours	36 months after diagnosis	Will be calculated at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is 36 months after diagnosis
Glycosylated hemoglobin A1 (HbA1c)	36 months after diagnosis	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

Trial Locations

Locations (1)

Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker; 🇳🇴 Oslo, Norway