NCT04230382

Brief Summary

The aims of the study are to determine the prevalence of diabetes in subgroups of the population with certain characteristics (age, gender, socioeconomic status, geographical area of residence), to estimate the proportion of those patients with diabetes treated without drugs, to estimate the proportion of the patients in which diabetes is not yet diagnosed, and to develop a proposal and recommendations for the development, implementation and evaluation of programs for the prevention and early diagnosis of diabetes. An analysis of the prevalence of diabetes in population subgroups and an estimate of the proportion of those patients who have non-drug treated diabetes will be drawn upon the data from the National Health and Health System Survey 2019, run by National Institute of Public Health. Methodologically it is a cross-sectional survey using a survey questionnaire based on the European Health Interview Survey. A sample of 16,000 inhabitants is invited to participate. The database contains sets of questions about health status, health markers and health care, and contains all the information that the research project covers. All those interviewees from the National Health and Health System Survey 2019 who are not aware to have diabetes will be invited to the health examination survey. They will be invited to perform an oral glucose tolerance test (once or twice, based on the results). In this way, diabetes can be diagnosed in those individuals who already have diabetes, but have not yet been aware of it. Secondary analyses of the data and the measurement of HbA1c from the sample of blood taken at the same collection will also give the opportunity to assess for example, the prevalence of impaired fasting glucose, impaired glucose tolerance, their combinations, and obtain more data on the clinical meaning of oral glucose tolerance test versus HbA1c in diagnosing diabetes in Slovenian context. We estimate that approximately 1500-2000 people will perform the health examination survey part.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
563

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration 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

First Submitted

Initial submission to the registry

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

1.7 years

First QC Date

January 13, 2020

Last Update Submit

December 7, 2022

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 DiabetesUntreated diabetesEpidemiologyOGTToral glucose tolerance testHbA1cSerum magnesium

Outcome Measures

Primary Outcomes (1)

  • OGTT

    Positive oral glucose tolerance test

    2 months

Other Outcomes (2)

  • HbA1c

    2 months

  • S-Magnesium

    2 months

Study Arms (1)

Adults

Adults (above 18 years) with completed National Health and Health System Survey 2019 (without diagnosis of diabetes)

Diagnostic Test: Diagnosis of diabetes (OGTT)

Interventions

Diagnosis of diabetes (OGTT)DIAGNOSTIC_TEST

Blood sample will be collected for glucose, HbA1c and magnesium. Standard OGTT will be conducted with 75g of glucose (repeated, if disgnostic).

Adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Representative population for Slovenia

You may qualify if:

  • Completed Slovenian National Health and Health System Survey 2019
  • Without diagnosed diabetes (self-reported information from the survey)
  • Signed study conscent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Public Health, Slovenia

Ljubljana, 1000, Slovenia

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected for measurement of biomarkers (glucose, HbA1c magnesium)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Ivan Erzen, PhD

    National Institute of Public Health, Slovenia

    STUDY CHAIR

  • Jelka Zaletel, PhD

    National Institute of Public Health, Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 18, 2020

Study Start

January 20, 2020

Primary Completion

September 15, 2021

Study Completion

April 30, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Locations

SL(1)