Type 2 Diabetes Mellitus Prevention Ukraine (T2DPUA)

Komisarenko Institute of Endocrinology and Metobolism

Status and phase: Completed; Phase 2

Conditions: Impaired Glucose Tolerance; Impaired Fasting Glucose; Type 2 Diabetes

Treatments: Other: Macronutrient modification; Other: Physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT04283201

0118U002166

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Diet

Experimental group

Treatment:

Other: Macronutrient modification

Physical activity

Experimental group

Treatment:

Other: Physical activity

Other: Macronutrient modification