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OpenTrials
Completed

NCT Number: NCT06167616

Infections and Latent Autoimmune Diabetes in Adults

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.

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Key information

Conditions

Latent Autoimmune Diabetes in Adults Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Infections Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska institute

Stockholm, 17177, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Less than 35 years

Treatment and study plan

Primary outcomes

  1. LADA

    Time frame: Up to 10 years

    ≥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).

Secondary outcomes

  1. Type 2 diabetes

    Time frame: Up to 10 years

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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Novo Nordisk A/S
  • Swedish Council for Working Life and Social Research
  • The Swedish Research Council

Registry information

Official study title

Infections and Genetic Susceptibility in LADA and Type 2 Diabetes

Acronym: LADA

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2023
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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