Beta Cell Function in (Pre) Type 1 Diabetes

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AZ-VUB

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