Bialystok Exercise Study in Diabetes (BESD)

Medical University of Bialystok

Status: Unknown

Conditions: Overweight; Dyslipidemias; Obesity; Type 2 Diabetes; PreDiabetes

Treatments: Behavioral: Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04634890

R-I- 002/469/2014

Details and patient eligibility

About

The "Bialystok Exercise Study in Diabetes" (BESD), is an exercise intervention study, conducted by the Department of Endocrinology, Diabetology and Internal Medicine and Clinical Research Centre of the Medical University of Bialystok. In the project, sedentary males at different stages of dysglycemia living in the city of Bialystok participate in three months of an exercise intervention consisting of supervised training sessions at a local fitness centre. The aim of the study is to assess the effectiveness of the exercise intervention in patients at different stages of dysglycemia progression, including type 2 diabetes and prediabetes and compare the response between groups.

Enrollment: 300 estimated patients

Sex: Male

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 35-65 years old
• BMI: 25-35 kg/m2
• Male gender
• Ability of performing exercise trainings
• Sedentary lifestyle

Exclusion criteria

• Smoking
• Drug or alcohol addiction
• Any chronic disease (exceptions: hypertension, obesity with BMI ≤ 35 kg/m2, type 2 diabetes)
• Any chronic medications (exceptions: angiotensin-converting-enzyme inhibitors for hypertension and metformin in type 2 diabetics)
• Highly active lifestyle
• Medical contraindications to participate in planned exercise sessions

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Type 2 Diabetes

Other group

Description:

Subjects with type 2 diabetes, diagnosed within the last 3-5 years, treated with metformin only as an anti-diabetic drug

Treatment:

Behavioral: Exercise intervention

Prediabetes

Other group

Description:

Subjects with prediabetes, defined as impaired fasting glucose or/and impaired glucose tolerance

Treatment:

Behavioral: Exercise intervention

Normoglycemia

Other group

Description:

Subjects with normal fasting glucose and normal glucose tolerance

Treatment:

Behavioral: Exercise intervention