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Type 2 Diabetes Mellitus Prevention Ukraine (T2DPUA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283201
Recruitment Status : Active, not recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Mykola Khalangot, Komisarenko Institute of Endocrinology and Metobolism

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

Condition or disease Intervention/treatment Phase
Evaluation of Lifestyle Modification for the Prevention of Type 2 Diabetes Other: Lifestyle modification Early Phase 1

Detailed Description:
Persons with impaired fasting plasma blood glucose levels and / or impaired glucose tolerance will receive personalized recommendations for diet and physical activity. Plasma blood glucose levels will be monitored periodically.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Development, Implementation and Evaluation of the Effectiveness of Recommendations for the Prevention of Type 2 Diabetes in Ukraine
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diet Other: Lifestyle modification
Macronutrient and physical activity evaluation and modification

Experimental: Physical activity Other: Lifestyle modification
Macronutrient and physical activity evaluation and modification




Primary Outcome Measures :
  1. New type 2 diabetes cases [ Time Frame: 3 month ]
    fasting blood glucose level >=6.1 mmol/l



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Persons with impaired fasting plasma blood glucose levels and / or impaired glucose tolerance

Exclusion Criteria:

Known diabetes


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283201


Locations
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Ukraine
V.P.Komisarenko Institute of Endocrinology and Metabolism
Kyiv, Ukraine, 04114
Sponsors and Collaborators
Komisarenko Institute of Endocrinology and Metobolism
Investigators
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Study Director: Victor Kravchenko, PhD, Prof V.P.Komisarenko Institute of Endocrinology and Metabolism
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Responsible Party: Mykola Khalangot, Clinical Professor, Senior Researcher, Komisarenko Institute of Endocrinology and Metobolism
ClinicalTrials.gov Identifier: NCT04283201    
Other Study ID Numbers: 0118U002166
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mykola Khalangot, Komisarenko Institute of Endocrinology and Metobolism:
lifestyle modification
type 2 diabetes
prevention
Ukraine
Rural
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases