Beta Cell Function in (Pre) Type 1 Diabetes

December 27, 2013 updated by: Bart Keymeulen, AZ-VUB
This study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • Universitair Ziekenhuis Antwerpen
      • Brussels, Belgium, 1090
        • UZ Brussels
      • Gent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: FDR of type 1 diabetes patients receiving glucose 20%
First Degree Relatives of diabetes type 1 patient with a high, intermedian or low risk (accoring to the criteria of the protocol), for developing diabetes type 1.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ-VUB

Investigators

  • Principal Investigator: katelijn Decochez, MD PhD, UZ Brussels

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

November 28, 2008

First Submitted That Met QC Criteria

November 28, 2008

First Posted (Estimate)

December 1, 2008

Study Record Updates

Last Update Posted (Estimate)

December 30, 2013

Last Update Submitted That Met QC Criteria

December 27, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KD_BF_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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