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NCT04283201 Clinical Trial

Type 2 Diabetes Mellitus Prevention Ukraine

Type 2 Diabetes Clinical Trial

— T2DPUA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04283201
Other study ID # 0118U002166
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 20, 2020
Est. completion date December 31, 2021

Study information
Verified date August 2022
Source Komisarenko Institute of Endocrinology and Metobolism
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 31, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 79 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Physical activity
Moderate activity 150 min per week
• Macronutrient modification
Insoluble dietary fiber 15 g per day (Vitacel wheat fiber); sugar limitation

Locations
Country Name City State
Ukraine V.P.Komisarenko Institute of Endocrinology and Metabolism Kyiv

Sponsors (1)
Lead Sponsor Collaborator
Komisarenko Institute of Endocrinology and Metobolism

Country where clinical trial is conducted

Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary New type 2 diabetes cases fasting blood glucose level >=6.1 mmol/l 3 month
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