Infections and Latent Autoimmune Diabetes in Adults | NCT06167616

Studies
Infections and Latent Autoimmune Diabetes in Adults

NCT06167616

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Dec 12, 2023Actual

Enrollment

5,048Actual

Phase

Not provided

Conditions

Latent Autoimmune Diabetes in Adults
Type 2 Diabetes

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
2018-03035	Other Grant/Funding Number	Swedish Research Council
2018-00337	Other Grant/Funding Number	FORTE
NNF19OC0057274	Other Grant/Funding Number	Novo Nordisk Foundation

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2010Actual

Primary Completion Date

Oct 31, 2019Actual

Completion Date

Oct 31, 2019Actual

First Submitted Date

Nov 27, 2023

First Submission Date that Met QC Criteria

Dec 11, 2023

First Posted Date

Dec 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2023

Last Update Posted Date

Dec 12, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sofia Carlsson, Associate professor, Karolinska InstitutetPrincipal Investigator

Lead Sponsor

Karolinska InstitutetOTHER

Collaborators

Name	Class
The Swedish Research Council	OTHER_GOV
Swedish Council for Working Life and Social Research	OTHER
Novo Nordisk A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,048Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Less than 35 years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sofia Carlsson, PhD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska institute		Stockholm		17177	Sweden

Label	URL
ESTRID website	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000071698	Latent Autoimmune Diabetes in Adults
D003924	Diabetes Mellitus, Type 2
D007239	Infections
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

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