Back to resultsType 2 Diabetes Mellitus Prevention Ukraine (T2DPUA)
Primary Purpose
Impaired Fasting Glucose, Impaired Glucose Tolerance, Type 2 Diabetes
Status
Completed
Phase
Phase 2
Locations
Ukraine
Study Type
Interventional
Intervention
Physical activity
Macronutrient modification
Sponsored by
About this trial
This is an interventional prevention trial for Impaired Fasting Glucose focused on measuring lifestyle modification, type 2 diabetes, prevention, Ukraine, Rural
Eligibility Criteria
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
Sites / Locations
- V.P.Komisarenko Institute of Endocrinology and Metabolism
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diet
Physical activity
Arm Description
Outcomes
Primary Outcome Measures
New type 2 diabetes cases
fasting blood glucose level >=6.1 mmol/l
Secondary Outcome Measures
Full Information
NCT ID
NCT04283201
First Posted
February 20, 2020
Last Updated
August 24, 2022
Sponsor
Komisarenko Institute of Endocrinology and Metobolism
1. Study Identification
Unique Protocol Identification Number
NCT04283201
Brief Title
Type 2 Diabetes Mellitus Prevention Ukraine
Acronym
T2DPUA
Official Title
Development, Implementation and Evaluation of the Effectiveness of Recommendations for the Prevention of Type 2 Diabetes in Ukraine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Komisarenko Institute of Endocrinology and Metobolism
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Fasting Glucose, Impaired Glucose Tolerance, Type 2 Diabetes
Keywords
lifestyle modification, type 2 diabetes, prevention, Ukraine, Rural
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet
Arm Type
Experimental
Arm Title
Physical activity
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Description
Moderate activity 150 min per week
Intervention Type
Other
Intervention Name(s)
Macronutrient modification
Intervention Description
Insoluble dietary fiber 15 g per day (Vitacel wheat fiber); sugar limitation
Primary Outcome Measure Information:
Title
New type 2 diabetes cases
Description
fasting blood glucose level >=6.1 mmol/l
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Kravchenko, PhD, Prof
Organizational Affiliation
V.P.Komisarenko Institute of Endocrinology and Metabolism
Official's Role
Study Director
Facility Information:
Facility Name
V.P.Komisarenko Institute of Endocrinology and Metabolism
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Type 2 Diabetes Mellitus Prevention Ukraine
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