Diabetes Virus Detection Project, Intervention With GAD-alum (DiViD)

University of Oslo (UIO)

Status and phase: Terminated; Phase 2

Conditions: Autoimmunity; Enterovirus Infections; Diabetes, Type I

Treatments: Drug: GAD-alum; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01129232

2009/1907 (REK)

2008-002027-82 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups, including a placebo group

GAD-alum

Experimental group

Description:

GAD-alum administered at 0 and 1 months after inclusion

Treatment:

Drug: GAD-alum

Placebo

Placebo Comparator group

Treatment:

Other: Placebo