Autoimmune Diabetes: Markers of the Disease and Treatment of Latent Autoimmune Diabetes in Adults (LADA)

Withdrawn

• Conditions: Autoimmune Diabetes

• Registration Number: NCT01148238
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

Autoimmunity is the main cause of diabetes type 1 and an important factor as cause of Latent Autoimmune Diabetes in Adults (LADA). Recently, research has found that being deficient of T-reg cells is an important cause of autoimmunity. The study hypothesis are:

1. Patients with newly found diabetes type 1 have less T-reg than healthy.

2. Patients with newly found diabetes type 1 have less T-reg than patients with long duration of the illness.

3. The number of T-reg is negative associated with HLA-risk-haplotype.

4. The number of T-reg is negative associated with LADA.

5. Differences relating to inflammatory cytokines will be seen among patients with newly found diabetes type 1, but not among others.

Detailed Description

Research has worked out that b-cells are being destroyed by cytokines released from inflammatory cells. One hypothesis in that T-reg is a cause of autoimmunity, and that T-reg concentrations are low in patients with newly diagnosed diabetes type 1.

Blood samples will be taken from 10 patients with newly diagnosed type 1 diabetes, Latent Autoimmune Diabetes in Adults (LADA) and type 1 diabetes older than 10 years and the same amount of samples from healthy, age- and sex-matched blood donors. Markers of autoimmune diabetes will be analyzed.

Study Timeline

• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Study Start: 2012-08
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-07
• Last Update Posted: 2012-12-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• newly diagnosed diabetes type 1
• LADA
• diabetes type 1 older than 10 years

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T-reg		??????

Secondary Outcome Measures

Name	Time	Method
HLA, anti-GAD, anti-IA2, white blood count, CRP, fasting C-peptide, HbA1c		?????