Impaired Fasting GlucosePhase 2T2DPUANCT04283201
Type 2 Diabetes Mellitus Prevention Ukraine
A Phase 2 study testing Physical activity and Macronutrient modification in people with Impaired Fasting Glucose and Impaired Glucose Tolerance, run by Komisarenko Institute of Endocrinology and Metobolism at 1 site in Ukraine.
Trial summary
Development, implementation and evaluation of the effectiveness of lifestyle recommendations for the prevention of type 2 diabetes in rural population of Ukraine Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Fasting Glucose, Impaired Glucose Tolerance, Type 2 Diabetes
- What is being tested?
- Physical activity and Macronutrient modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUkraine
- Study dates
- 20 Feb 2020to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons with fasting blood glucose level >=6.1 mmol/l; persons aged 18-79 who signed an informed consent for the study.
Who cannot join
- Known diabetes; acute infectious diseases; other serious diseases
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
V.P.Komisarenko Institute of Endocrinology and Metabolism
Kyiv, 04114
About this study
Official title: 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
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.
- Being tested
- Physical activity, Macronutrient modification
- Keywords
- lifestyle modification, type 2 diabetes, prevention, Ukraine, Rural
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Moderate activity 150 min per week
Macronutrient modificationOther
Insoluble dietary fiber 15 g per day (Vitacel wheat fiber); sugar limitation
| Study group | Role | What they receive |
|---|---|---|
| Diet | Experimental | Not described Receives: Other: Macronutrient modification |
| Physical activity | Experimental | Not described Receives: Other: Physical activity; Other: Macronutrient modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
New type 2 diabetes cases
fasting blood glucose level >=6.1 mmol/l
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start20 Feb 2020
- Primary completion1 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impaired Fasting GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Komisarenko Institute of Endocrinology and Metobolism
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mykola Khalangot, Komisarenko Institute of Endocrinology and Metobolism
- Investigators
- Victor Kravchenko, PhD, Prof, Study director, V.P.Komisarenko Institute of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283201
- Sponsor's protocol ID
- 0118U002166
- Acronym
- T2DPUA
- Status last verified
- Aug 2022
- First submitted
- 20 Feb 2020
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khalangot M, Krasnienkov D, Gurianov V, Zakharchenko T, Barsukov O, Midlovets K, Kravchenko V, Tronko M. Metabolic and Antioxidant Status, Telomere Lengths of Individuals With Prediabetes in Context of 3 Months of Insoluble Dietary Fibre Intake During the SARS-CoV2 Pandemic. Endocrinol Diabetes Metab. 2026 May;9(3):e70210. doi: 10.1002/edm2.70210.
PubMed 41891171
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Implementation and Evaluation of the Effectiveness of Recommendations for the Prevention of Type 2 Diabetes in Ukraine
- ClinicalTrials.gov ID
- NCT04283201
- Acronym / sponsor ID
- T2DPUA / 0118U002166
- Keywords
- lifestyle modification, type 2 diabetes, prevention, Ukraine, Rural
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Komisarenko Institute of Endocrinology and MetobolismOther government
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diet | Experimental | Other: Macronutrient modification |
| Physical activity | Experimental | Other: Physical activity, Other: Macronutrient modification |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons with fasting blood glucose level >=6.1 mmol/l; persons aged 18-79 who signed an informed consent for the study.
Key exclusion criteria (1 listed)
- Known diabetes; acute infectious diseases; other serious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityModerate activity 150 min per week | Other | Physical activity |
| Macronutrient modificationInsoluble dietary fiber 15 g per day (Vitacel wheat fiber); sugar limitation | Other | Diet, Physical activity |
Primary outcome
New type 2 diabetes cases
Time frame: 3 month
fasting blood glucose level >=6.1 mmol/l
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Derived from this study: PubMed 41891171Khalangot M, Krasnienkov D, Gurianov V, Zakharchenko T, Barsukov O, Midlovets K, Kravchenko V, Tronko M. Metabolic and Antioxidant Status, Telomere Lengths of Individuals With Prediabetes in Context of 3 Months of Insoluble Dietary Fibre Intake During the SARS-CoV2 Pandemic. Endocrinol Diabetes Metab. 2026 May;9(3):e70210. doi: 10.1002/edm2.70210.
- Individual participant dataSharing planned: No
Related trials for Impaired Fasting Glucose
Active, not recruitingPhase 2
Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.
PreDiabetes, Impaired Glucose Tolerance
Not yet recruitingObservational study
Multimodal Risk Factor Graph Mapping, Metabolic Subtyping, and Digital Intelligent Chronic Disease Management for Prediabetes: An Integrated Cohort and Case-Control Clinical Study
Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
Recruiting
Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
Diabetes Mellitus, Type 2, Impaired Glucose Tolerance (IGT)
Not yet recruitingObservational study
Growth Hormone Resistance of Beta-cells
Healthy, Obesity & Overweight
Not yet recruiting
Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control
Obesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Kravchenko, PhD, Prof study director
V.P.Komisarenko Institute of Endocrinology and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physical activity and Macronutrient modification in people with Impaired Fasting Glucose and Impaired Glucose Tolerance, run by Komisarenko Institute of Endocrinology and Metobolism at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New type 2 diabetes cases (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04283201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.