Type 2 Diabetes Mellitus Prevention Ukraine

Phase 2

Completed

• Conditions: Impaired Glucose Tolerance; Type 2 Diabetes; Impaired Fasting Glucose
• Interventions: Other: Macronutrient modification; Other: Physical activity

• Registration Number: NCT04283201
• Lead Sponsor: Komisarenko Institute of Endocrinology and Metobolism

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.

Study Timeline

• Study Start: 2020-02-20
• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-25
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet	Macronutrient modification	-
Physical activity	Physical activity	-
Physical activity	Macronutrient modification	-

Primary Outcome Measures

Name	Time	Method
New type 2 diabetes cases	3 month	fasting blood glucose level \>=6.1 mmol/l

Trial Locations

Locations (1)

V.P.Komisarenko Institute of Endocrinology and Metabolism; 🇺🇦 Kyiv, Ukraine