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Status:

UNKNOWN

Beta Cell Function in (Pre) Type 1 Diabetes

Lead Sponsor:

AZ-VUB

Conditions:

Type 1 Diabetes

Eligibility:

All Genders

5-40 years

Phase:

PHASE1

PHASE2

Brief Summary

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

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 t...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2015

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00800085

Start Date

October 1 2006

End Date

October 1 2015

Last Update

December 30 2013

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

2

UZ Brussels

Brussels, Belgium, 1090

3

UZ Gent

Ghent, Belgium, 9000

4

UZ Leuven

Leuven, Belgium, 3000