Beta Cell Function in (Pre) Type 1 Diabetes

Phase 1

• Conditions: Type 1 Diabetes
• Interventions: Drug: glucose 20%

• Registration Number: NCT00800085
• Lead Sponsor: AZ-VUB

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 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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-11-28
• Study First Submitted QC: 2008-11-28
• Study First Posted: 2008-12-01
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-27
• Last Update Posted: 2013-12-30
• Primary Completion: 2014-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FDR of type 1 diabetes patients receiving glucose 20%	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.

Primary Outcome Measures

Name	Time	Method
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	48 months

Trial Locations

Locations (4)

UZ Brussels; 🇧🇪 Brussels, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium