Diabetes Virus Detection Project, Intervention With GAD-alum

NCT ID: NCT01129232

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Diabetes, Type I; Enterovirus Infections; Autoimmunity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GAD-alum

GAD-alum administered at 0 and 1 months after inclusion

Group Type: EXPERIMENTAL

GAD-alum

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

GAD-alum

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Diamyd

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lars Krogvold

Assosciate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Knut Dahl-Jorgensen, Prof

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker

Oslo, , Norway

Countries

Norway

Other Identifiers

2008-002027-82

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2009/1907 (REK)

Identifier Type: -

Identifier Source: org_study_id