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Clinical Trials/NCT04283201
NCT04283201
Completed
Phase 2

Development, Implementation and Evaluation of the Effectiveness of Recommendations for the Prevention of Type 2 Diabetes in Ukraine

Komisarenko Institute of Endocrinology and Metobolism1 site in 1 country30 target enrollmentFebruary 20, 2020

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Impaired Fasting Glucose
Sponsor
Komisarenko Institute of Endocrinology and Metobolism
Enrollment
30
Locations
1
Primary Endpoint
New type 2 diabetes cases
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Development, implementation and evaluation of the effectiveness of lifestyle recommendations for the prevention of type 2 diabetes in rural population of Ukraine

Detailed Description

An oral glucose tolerance test and anthropometric measurements were performed for 300 randomly selected rural residents of the Kyiv region of Ukraine. Persons from impaired glucose regulation category (impaired fasting glucose - IFG) was enrolled to diabetes prevention intervention study (T2DPUA). Individuals in the IFG category received advice on limiting sugar intake (not more than 25 g per day), increasing physical activity (30 minutes daily). 30 persons from this category were additionally advised to consume insoluble dietary fiber 15 g per day (Vitacel wheat fiber) for 3 months, after which a repeat anthropometric and biochemical study. Objective control of physical activity and body composition is also provided.

Registry
clinicaltrials.gov
Start Date
February 20, 2020
End Date
December 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Komisarenko Institute of Endocrinology and Metobolism
Responsible Party
Principal Investigator
Principal Investigator

Mykola Khalangot

Clinical Professor, Principal Investigator

Komisarenko Institute of Endocrinology and Metobolism

Eligibility Criteria

Inclusion Criteria

  • Persons with fasting blood glucose level \>=6.1 mmol/l; persons aged 18-79 who signed an informed consent for the study.

Exclusion Criteria

  • Known diabetes; acute infectious diseases; other serious diseases

Outcomes

Primary Outcomes

New type 2 diabetes cases

Time Frame: 3 month

fasting blood glucose level \>=6.1 mmol/l

Study Sites (1)

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