Type 2 Diabetes Mellitus Prevention Ukraine

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

Detailed Description
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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.

Official Title
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Development, Implementation and Evaluation of the Effectiveness of Recommendations for the Prevention of Type 2 Diabetes in Ukraine

Conditions
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Impaired Fasting Glucose, Impaired Glucose Tolerance, Type 2 Diabetes

Intervention / Treatment
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* Other: Physical activity
* Other: Macronutrient modification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet<br> | Other: Macronutrient modification<br>* Insoluble dietary fiber 15 g per day (Vitacel wheat fiber); sugar limitation<br>|
| Experimental: Physical activity<br> | Other: Physical activity<br>* Moderate activity 150 min per week<br>Other: Macronutrient modification<br>* Insoluble dietary fiber 15 g per day (Vitacel wheat fiber); sugar limitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New type 2 diabetes cases | fasting blood glucose level >=6.1 mmol/l | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lifestyle modification, type 2 diabetes, prevention, Ukraine, Rural