Clinical trial NCT04634890: Bialystok Exercise Study in Diabetes
Official title: Bialystok Exercise Study in Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
PreDiabetes
Overweight
Obesity
Dyslipidemias
Keywords: exercise intervention
type 2 diabetes prevention
type 2 diabetes treatment
prediabetes
behavioural intervention
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2020-11-18
Enrollment: 300
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: Three months
measure: Fasting glucose
timeFrame: Three months
measure: 2-hour glucose
timeFrame: Three months
measure: Fasting insulin
timeFrame: Three months
measure: Lean body mass
timeFrame: Three months
measure: Fat mass
timeFrame: Three months
measure: Visceral Adipose Tissue mass
timeFrame: Three months
measure: Weight
timeFrame: Three months
measure: HOMA-IR
timeFrame: Three months
measure: HOMA-beta
timeFrame: Three months
measure: VO2max
timeFrame: Three months
measure: Triglycerides (TG)
timeFrame: Three months
measure: High-density lipoprotein cholesterol (HDL)
timeFrame: Three months
measure: Low-density lipoprotein cholesterol (LDL)
timeFrame: Three months
measure: Total cholesterol
timeFrame: Three months
Secondary outcomes:
measure: Plasma metabolome
timeFrame: Three months
measure: Skeletal muscle metabolome
timeFrame: Three months
measure: Subcutaneous adipose tissue metabolome
timeFrame: Three months
measure: Skeletal muscle transcriptome
timeFrame: Three months
measure: Subcutaneous adipose tissue transcriptome
timeFrame: Three months
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Clinical Research Centre, Medical University of Bialystok
state: Podlaskie
Study officials:
References: