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

NCT ID: NCT01148238

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Autoimmune Diabetes

Keywords

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Autoimmune diabetes LADA T-reg cytokine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

LADA

Blood samples will be taken from 10 patients with LADA and 10 healthy age-and sexmatched controls.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valdemar Grill, M.D, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cancer Research and Molecular Medicine

Countries

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Norway

Other Identifiers

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AUTO

Identifier Type: -

Identifier Source: org_study_id