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

December 7, 2012 updated by: Norwegian University of Science and Technology

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

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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

10 patients with newly diagnosed diabetes type 1. 10 healthy age- and sex matched blood donors.

10 patients with LADA. 10 healthy age- and sex matched blood donors. 10 patients with diabetes type 1 older than 10 years. 10 healthy age- and sex matched blood donors.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diabetes type 1 older than 10 years
Blood samples will be taken from 10 patients with diabetes type 1 older than 10 years and 10 healthy age-and sexmatched controls.
Newly diagnosed type 1 diabetes
Blood samples will be taken from 10 patients with newly diagnosed type 1 diabetes and 10 healthy age-and sexmatched controls.
LADA
Blood samples will be taken from 10 patients with LADA and 10 healthy age-and sexmatched controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
T-reg
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Secondary Outcome Measures

Outcome Measure
Measure Description
HLA, anti-GAD, anti-IA2, white blood count, CRP, fasting C-peptide, HbA1c
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Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Valdemar Grill, M.D, PhD, Department of Cancer Research and Molecular Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 10, 2012

Last Update Submitted That Met QC Criteria

December 7, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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