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Completed

NCT Number: NCT04283201

Type 2 Diabetes Mellitus Prevention Ukraine

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

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Key information

Conditions

Impaired Fasting Glucose Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Impaired Glucose Tolerance Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

V.P.Komisarenko Institute of Endocrinology and Metabolism

Kyiv, 04114, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Other

Moderate activity 150 min per week

Macronutrient modification

Other

Insoluble dietary fiber 15 g per day (Vitacel wheat fiber); sugar limitation

Primary outcomes

  1. New type 2 diabetes cases

    Time frame: 3 month

    fasting blood glucose level >=6.1 mmol/l

Sponsors and collaborators

Lead sponsor

Komisarenko Institute of Endocrinology and Metobolism

Other Gov

Registry information

Official study title

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

Acronym: T2DPUA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2020
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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