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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2011 by Oslo University Hospital
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01129232
First received: May 11, 2010
Last updated: May 3, 2011
Last verified: April 2011
  Purpose

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).


Condition Intervention Phase
Diabetes, Type I
Enterovirus Infections
Autoimmunity
Drug: GAD-alum
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies [ Time Frame: 18 months after inclusion ] [ Designated as safety issue: No ]
  • Prevalence of virus infected islets in pancreatic biopsies [ Time Frame: 18 months after inclusion ] [ Designated as safety issue: No ]
  • Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies [ Time Frame: 2 weeks after inclusion ] [ Designated as safety issue: No ]
  • Prevalence of virus infected islets in pancreatic biopsies [ Time Frame: 2 weeks after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test [ Time Frame: 36 months after diagnosis ] [ Designated as safety issue: No ]
    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 [ Time Frame: 36 months after diagnosis ] [ Designated as safety issue: No ]
    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) [ Time Frame: 36 months after diagnosis ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GAD-alum
GAD-alum administered at 0 and 1 months after inclusion
Drug: GAD-alum
20 µg of GAD-alum injected sc after the biopsy, and repeated after one month
Other Name: Diamyd
Placebo Comparator: Placebo Other: Placebo
Placebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm)
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129232

Contacts
Contact: Lars Krogvold, MD +47 97522277 lars.krogvold@medisin.uio.no
Contact: Knut Dahl-Jørgensen, Prof +47 22119090 knut.dahl-jorgensen@medisin.uio.no

Locations
Norway
Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker Recruiting
Oslo, Norway, 0514
Contact: Lars Krogvold, MD    +47 97522277    lars.krogvold@medisin.uio.no   
Contact: Trine Roald, Nurse    +47 91785647    trine.roald@medisin.uio.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Knut Dahl-Jorgensen, Prof Oslo University Hospital
  More Information

No publications provided

Responsible Party: Knut Dahl-Jørgensen, professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01129232     History of Changes
Other Study ID Numbers: 2009/1907 (REK), 2008-002027-82
Study First Received: May 11, 2010
Last Updated: May 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Enterovirus Infections
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Aluminum sulfate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014