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Infections and Latent Autoimmune Diabetes in Adults

NCT ID: NCT06167616

Last Updated: 2023-12-12

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

COMPLETED

Total Enrollment

5048 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-01

Study Completion Date

2019-10-31

Brief Summary

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Infections are proposed risk factors for type 1 diabetes in children. The investigators will examine whether a diagnosis of infectious disease also confers an increased risk of latent autoimmune diabetes in adults.

Detailed Description

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The investigators will use data from a population-based Swedish case-control study (ESTRID) with incident cases of LADA (n=597) and matched controls (n=2386). History of infectious disease are ascertained through national and regional patient registers. The investigators will estimate adjusted odds ratios (OR) with 95% CI for ≥1 respiratory (any/upper/lower), gastrointestinal, herpetic, other or any infectious disease episode, or separately, for 1 and ≥2 infectious disease episodes, within 0-1, 1-3, 3-5 and 5-10 years before LADA diagnosis/matching. Stratified analyses will be performed based on HLA risk genotypes and GADA levels.

Conditions

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Latent Autoimmune Diabetes in Adults Type 2 Diabetes

Keywords

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Latent Autoimmune Diabetes in Adults Infections Diabetes Mellitus Type 2 diabetes Case-Control Studies register study

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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LADA

Classification of LADA based on age ≥35 years at diagnosis, GADA positivity (≥10 U/ml) and C-peptide concentrations of ≥0.2 nmol/L (IMMULITE) or ≥0.3 nmol/L (Cobas).

No interventions assigned to this group

Type 2 diabetes

≥35 years, GADA negative and C-peptide concentrations of \>0.60 (IMMULITE)/\>0.72 (Cobas) nmol/L.

No interventions assigned to this group

Controls

≥35 years, free of diabetes

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 35 years or older, residing in Scania or Uppsala county.

Exclusion Criteria

* Less than 35 years
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Swedish Council for Working Life and Social Research

OTHER

Sponsor Role collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Sofia Carlsson

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sofia Carlsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska institute

Stockholm, , Sweden

Site Status

Countries

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Sweden

Related Links

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https://ki.se/en/imm/estrid

ESTRID website

Other Identifiers

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2018-03035

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2018-00337

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NNF19OC0057274

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022-00811_1

Identifier Type: -

Identifier Source: org_study_id