CClinicalTrials.gg
CompletedNCT04283201T2DPUAUpdated Aug 26, 2022

Type 2 Diabetes Mellitus Prevention Ukraine

A Phase 2 interventional study of Physical activity and Macronutrient modification in Impaired Fasting Glucose, Impaired Glucose Tolerance and Type 2 Diabetes, sponsored by Komisarenko Institute of Endocrinology and Metobolism. Completed at 1 site in Ukraine. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-26.

Sponsored by Komisarenko Institute of Endocrinology and Metobolism · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Impaired Fasting Glucose
  • Impaired Glucose Tolerance
  • Type 2 Diabetes

Keywords

  • lifestyle modification
  • type 2 diabetes
  • prevention
  • Ukraine
  • Rural
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with Komisarenko Institute of Endocrinology and Metobolism as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

Known diabetes; acute infectious diseases; other serious diseases

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Diet

    Other: Macronutrient modification

  • Experimental
    Physical activity

    Other: Physical activity · Other: Macronutrient modification

Interventions

  • OtherPhysical activity

    Moderate activity 150 min per week

  • OtherMacronutrient modification

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

06

What researchers measure

Primary outcomes

  1. New type 2 diabetes cases

    fasting blood glucose level \>=6.1 mmol/l

    Time frame: 3 month

07

Study locations

1 site
  • V.P.Komisarenko Institute of Endocrinology and Metabolism
    Kyiv, 04114, Ukraine
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04283201
Lead sponsor
Komisarenko Institute of Endocrinology and Metobolism
Responsible party
Mykola Khalangot (Clinical Professor, Principal Investigator, Komisarenko Institute of Endocrinology and Metobolism) — Principal investigator
First posted
Feb 25, 2020
Start date
Feb 20, 2020
Primary completion
Nov 1, 2021
Completion
Dec 31, 2021
Last update
Aug 26, 2022

Study contacts

Victor Kravchenko, PhD, Prof
study director · V.P.Komisarenko Institute of Endocrinology and Metabolism

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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