Text Size

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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01148238
First received: June 17, 2010
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • T-reg [ Time Frame: ? ] [ Designated as safety issue: No ]
    ??????


Secondary Outcome Measures:
  • HLA, anti-GAD, anti-IA2, white blood count, CRP, fasting C-peptide, HbA1c [ Time Frame: ? ] [ Designated as safety issue: No ]
    ?????


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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01148238     History of Changes
Other Study ID Numbers: AUTO
Study First Received: June 17, 2010
Last Updated: December 7, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on May 23, 2013