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

This study has been withdrawn prior to enrollment.
(changed research plan)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01148238
First Posted: June 22, 2010
Last Update Posted: December 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose

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.

Condition
Autoimmune Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autoimmune Diabetes: Disease Markers and Treatment of Latent Autoimmune Diabetes in Adults (LADA)

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • T-reg
    ??????


Secondary Outcome Measures:
  • HLA, anti-GAD, anti-IA2, white blood count, CRP, fasting C-peptide, HbA1c
    ?????


Biospecimen Retention:   Samples With DNA
Cytokines HLA T-reg

Enrollment: 0
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148238


Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Valdemar Grill, M.D, PhD Department of Cancer Research and Molecular Medicine
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01148238     History of Changes
Other Study ID Numbers: AUTO
First Submitted: June 17, 2010
First Posted: June 22, 2010
Last Update Posted: December 10, 2012
Last Verified: December 2012

Keywords provided by Norwegian University of Science and Technology:
Autoimmune diabetes
LADA
T-reg
cytokine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases


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