The Proportion of Patients With Non-diagnosed Diabetes Type 2

NCT04230382 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 563

Last updated 2022-12-08

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DIAGNOSTIC_TEST

Diagnosis of diabetes (OGTT)

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

Sponsors & Collaborators

  • National Institute of Public Health, Slovenia

    collaborator OTHER_GOV
  • Ministry of Health of Republic of Slovenia

    collaborator UNKNOWN
  • Slovenian Research Agency

    collaborator OTHER
  • Institute of Nutrition, Slovenia (Nutris)

    lead OTHER

Principal Investigators

  • Ivan Erzen, PhD · National Institute of Public Health, Slovenia

  • Jelka Zaletel, PhD · National Institute of Public Health, Slovenia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2021-09-15
Completion
2022-04-30

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04230382 on ClinicalTrials.gov