NCT00800085

Beta Cell Function in (Pre) Type 1 Diabetes

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 5 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-10-01
• Primary completion: 2014-10-01
• Completion: 2015-10-01
• First posted: 2008-12-01
• Last updated: 2013-12-30

Locations

4 sites across 1 country: Belgium