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NCT06167616 Clinical Trial

Infections and Latent Autoimmune Diabetes in Adults

Type 2 Diabetes Clinical Trial

— LADA  

Official title:
Infections and Genetic Susceptibility in LADA and Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06167616
Other study ID # 2022-00811_1
Secondary ID 2018-030352018-0
Status Completed
Phase
First received
Last updated
Start date September 1, 2010
Est. completion date October 31, 2019

Study information
Verified date December 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 5048
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years and older
Eligibility Inclusion Criteria: - 35 years or older, residing in Scania or Uppsala county. Exclusion Criteria: - Less than 35 years

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Karolinska institute Stockholm

Sponsors (4)
Lead Sponsor Collaborator
Karolinska Institutet Novo Nordisk A/S, Swedish Council for Working Life and Social Research, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary LADA =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). Up to 10 years
Secondary Type 2 diabetes also =35, GADA negative and had C-peptide concentrations of >0.60 (IMMULITE)/>0.72 (Cobas) nmol/L. Up to 10 years
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