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

Autoimmune Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01148238
• Other study ID #: AUTO
• Status: Withdrawn
• Phase: N/A
• First received: June 17, 2010
• Last updated: December 7, 2012
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• newly diagnosed diabetes type 1

• LADA

• diabetes type 1 older than 10 years

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autoimmune Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T-reg	??????		No
Secondary	HLA, anti-GAD, anti-IA2, white blood count, CRP, fasting C-peptide, HbA1c	?????		No