NCT06167616

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,048

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

9.2 years

First QC Date

November 27, 2023

Last Update Submit

December 11, 2023

Conditions

Latent Autoimmune Diabetes in AdultsType 2 Diabetes

Keywords

Latent Autoimmune Diabetes in AdultsInfectionsDiabetes MellitusType 2 diabetesCase-Control Studiesregister study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Type 2 diabetes

    Up to 10 years

Study Arms (3)

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).

Type 2 diabetes

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

Controls

≥35 years, free of diabetes

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Less than 35 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska institute

Stockholm, 17177, Sweden

Location

Related Links

MeSH Terms

Conditions

Latent Autoimmune Diabetes in AdultsDiabetes Mellitus, Type 2InfectionsDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sofia Carlsson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 12, 2023

Study Start

September 1, 2010

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)