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

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01148238
• Collaborator: (none)
• Enrollment: 0
• Duration (Months): 4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Diabetes

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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Autoimmune Diabetes: Disease Markers and Treatment of Latent Autoimmune Diabetes in Adults (LADA)
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. T-reg []

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Secondary Outcome Measures

1. HLA, anti-GAD, anti-IA2, white blood count, CRP, fasting C-peptide, HbA1c []

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Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• newly diagnosed diabetes type 1

• LADA

• diabetes type 1 older than 10 years

Exclusion Criteria:

• none

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Norwegian University of Science and Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT01148238
• Other Study ID Numbers: AUTO
• First Posted: Jun 22, 2010
• Last Update Posted: Dec 10, 2012
• Last Verified: Dec 1, 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; Latent Autoimmune Diabetes in Adults

Study Results

No Results Posted as of Dec 10, 2012