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Beta Cell Function in (Pre) Type 1 Diabetes

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
FWO
Information provided by:
AZ-VUB
ClinicalTrials.gov Identifier:
NCT00800085
First received: November 28, 2008
Last updated: December 16, 2008
Last verified: November 2008
History of Changes
  Purpose

This study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes.


Condition Intervention Phase
Type 1 Diabetes
 Drug: glucose 20%
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Beta Cell Function in (Pre) Type 1 Diabetes

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by AZ-VUB:

Primary Outcome Measures:
  • The systematic and simultaneous determination of markers of functional beta cell mass and immune status allows stratification according to the stage of the pathogenic process rather than according to a late metabolic consequence of this process [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2006
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: glucose 20%
    maintain glycemia at 180 mg/dL till 150 min. after start glucose infusion: with a maintenance dose computed at 5- to 10-minute intervals
Detailed Description:

This study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes. These criteria may help to determine the time point and type of prevention may contribute to the composition of homogeneous groups of study subjects (based on residual beta cell mass, homogeneous risk of beta cell destruction during intervention) and may lead to the identification of functional markers that could be used as surrogate endpoints. This may reduce the number of subjects needed to treat as well as the follow-up time necessary to study significant effects of the test substance.

  Eligibility

Ages Eligible for Study:   5 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The following groups of first degree relatives of type1 diabetes patients with normal glucose tolerance during OGTT (5-39 years) will be included after informed consent on the basis of their antibody status (n = 40 per group):

    • IA-2A-positives;
    • Ab.-positives (positive for at least 2 different Abs. (IAA, GADA and/or ICA) and/or persistently Ab.-positive for 1 of these Abs;
    • persistently Ab.-negatives.
  • 40 type 1 diabetes patients with the following criteria will be studied: 1) aged 12-39 years; 2) < 4 weeks of insulin treatment; 3) auto-Ab.-positive; 4) polyuria since < 6 months; 5) < 10% weight loss over the last 6 months; 6) informed consent.

Exclusion Criteria:

  • Pregnancy or lactation in women
  • Use of illicit drugs or overconsumption of alcohol (> 3 beers/day) or history of drug or alcohol abuse
  • Being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders
  • Having received antidepressant medications during the last 6 months
  • Treatment with immune modulating or diabetogenic medication (such as corticosteroids)
  • Presently participating in another clinical study
  • History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the subjects
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800085

Locations
Belgium
Universitair Ziekenhuis Antwerpen
Antwerpen, Belgium
UZ Brussels
Brussels, Belgium, 1090
UZ Gent
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
AZ-VUB
FWO
Investigators
Principal Investigator: katelijn Decochez, MD PhD UZ Brussels
  More Information

Publications:

Responsible Party: Prof. dr. K. Decochez, University Hospital Brussels
ClinicalTrials.gov Identifier: NCT00800085     History of Changes
Other Study ID Numbers: KD_BF_01
Study First Received: November 28, 2008
Last Updated: December 16, 2008
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by AZ-VUB:
first degree relatives of type 1 diabetes patients
hyperglycemic clamp test

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013