Type 2 Diabetes Mellitus Prevention Ukraine (T2DPUA)

August 24, 2022 updated by: Mykola Khalangot, Komisarenko Institute of Endocrinology and Metobolism

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Kyiv, Ukraine, 04114
        • V.P.Komisarenko Institute of Endocrinology and Metabolism

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diet
Other: Macronutrient modification
Insoluble dietary fiber 15 g per day (Vitacel wheat fiber); sugar limitation
EXPERIMENTAL: Physical activity
Other: Macronutrient modification
Insoluble dietary fiber 15 g per day (Vitacel wheat fiber); sugar limitation
Other: Physical activity
Moderate activity 150 min per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New type 2 diabetes cases
Time Frame: 3 month
fasting blood glucose level >=6.1 mmol/l
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Komisarenko Institute of Endocrinology and Metobolism

Investigators

  • Study Director: Victor Kravchenko, PhD, Prof, V.P.Komisarenko Institute of Endocrinology and Metabolism

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 20, 2020

Primary Completion (ACTUAL)

November 1, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (ACTUAL)

February 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0118U002166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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