Diabetes Virus Detection Project, Intervention With GAD-alum

Autoimmunity Clinical Trial

— DiViD  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01129232
• Other study ID #: 2009/1907 (REK)
• Secondary ID: 2008-002027-82
• Status: Terminated
• Phase: Phase 2
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: May 2018
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autoimmunity
• Diabetes, Type I
• Enterovirus Infections

Intervention

Drug:
• GAD-alum
20 µg of GAD-alum injected sc after the biopsy, and repeated after one month

Other:
• Placebo
Placebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm)

Locations

Country	Name	City	State
Norway	Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies		18 months after inclusion
Primary	Prevalence of virus infected islets in pancreatic biopsies		18 months after inclusion
Primary	Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies		2 weeks after inclusion
Primary	Prevalence of virus infected islets in pancreatic biopsies		2 weeks after inclusion
Secondary	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
Secondary	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	36 months after diagnosis
Secondary	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