NCT04283201

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

February 20, 2020

Last Update Submit

August 24, 2022

Conditions

Impaired Fasting GlucoseImpaired Glucose ToleranceType 2 Diabetes

Keywords

lifestyle modificationtype 2 diabetespreventionUkraineRural

Outcome Measures

Primary Outcomes (1)

  • New type 2 diabetes cases

    fasting blood glucose level \>=6.1 mmol/l

    3 month

Study Arms (2)

Diet

EXPERIMENTAL
Other: Macronutrient modification

Physical activity

EXPERIMENTAL
Other: Physical activityOther: Macronutrient modification

Interventions

Physical activityOTHER

Moderate activity 150 min per week

Physical activity
Macronutrient modificationOTHER

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

DietPhysical activity

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons with fasting blood glucose level \>=6.1 mmol/l; persons aged 18-79 who signed an informed consent for the study.

You may not qualify if:

  • Known diabetes; acute infectious diseases; other serious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

V.P.Komisarenko Institute of Endocrinology and Metabolism

Kyiv, 04114, Ukraine

Location

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Victor Kravchenko, PhD, Prof

    V.P.Komisarenko Institute of Endocrinology and Metabolism

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Principal Investigator

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 25, 2020

Study Start

February 20, 2020

Primary Completion

November 1, 2021

Study Completion

December 31, 2021

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

UA(1)