Type 2 DiabetesBESDNCT04634890
Bialystok Exercise Study in Diabetes
A study testing Exercise intervention in people with Type 2 Diabetes and PreDiabetes, run by Medical University of Bialystok at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, PreDiabetes, Overweight
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 11 Aug 2016to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 35-65 years old
- BMI: 25-35 kg/m2
- Male gender
- Ability of performing exercise trainings
- Sedentary lifestyle
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Poland1 site
Clinical Research Centre, Medical University of Bialystok
Bialystok, Podlaskie Voivodeship, 15-276
About this study
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.
- Conditions
- Type 2 Diabetes, PreDiabetes, Overweight, Obesity, Dyslipidemias
- Being tested
- Exercise intervention
- Keywords
- exercise intervention, type 2 diabetes prevention, type 2 diabetes treatment, prediabetes, behavioural intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Overweight, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
Supervised exercise intervention composed of mixed aerobic and strength activities, with the frequency of 3 sessions per week for 12 weeks, for a total number of trainings of 36.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | Other | Subjects with type 2 diabetes, diagnosed within the last 3-5 years, treated with metformin only as an anti-diabetic drug Receives: Behavioral: Exercise intervention |
| Prediabetes | Other | Subjects with prediabetes, defined as impaired fasting glucose or/and impaired glucose tolerance Receives: Behavioral: Exercise intervention |
| Normoglycemia | Other | Subjects with normal fasting glucose and normal glucose tolerance Receives: Behavioral: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
Measured: Three months
Fasting glucose
Fasting glucose concentration measured in plasma using the colorimetric method
Measured: Three months
2-hour glucose
Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method
Measured: Three months
Fasting insulin
Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Measured: Three months
Lean body mass
Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Measured: Three months
Fat mass
Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Measured: Three months
Visceral Adipose Tissue mass
Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Measured: Three months
Weight
Total body weight measured using standardized scale
Measured: Three months
HOMA-IR
Homeostatic model assessment for insulin resistance
Measured: Three months
HOMA-beta
Homeostatic model assessment of beta cell function
Measured: Three months
VO2max
Maximal oxygen consumption measured during cardio-pulmonary exercise test on treadmill
Measured: Three months
Triglycerides (TG)
Serum triglycerides concentration measured using colorimetric method
Measured: Three months
High-density lipoprotein cholesterol (HDL)
Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method
Measured: Three months
Low-density lipoprotein cholesterol (LDL)
Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Measured: Three months
Total cholesterol
Serum total cholesterol concentration measured using colorimetric method
Measured: Three months
Secondary outcomes (5)
Plasma metabolome
Changes in plasma metabolites concentrations measured using untargeted metabolomics
Measured: Three months
Skeletal muscle metabolome
Changes in skeletal muscle metabolites concentrations measured using untargeted metabolomics
Measured: Three months
Subcutaneous adipose tissue metabolome
Changes in subcutaneous adipose tissue metabolites concentrations measured using untargeted metabolomics
Measured: Three months
Skeletal muscle transcriptome
Changes in skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
Measured: Three months
Subcutaneous adipose tissue transcriptome
Changes in subcutaneous adipose tissue gene and smallRNA expressions measured using untargeted transcriptomics
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start11 Aug 2016
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634890
- Sponsor's protocol ID
- R-I- 002/469/2014
- Acronym
- BESD
- Status last verified
- May 2025
- First submitted
- 12 Nov 2020
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bialystok Exercise Study in Diabetes
- ClinicalTrials.gov ID
- NCT04634890
- Acronym / sponsor ID
- BESD / R-I- 002/469/2014
- Conditions
- Type 2 Diabetes, PreDiabetes, Overweight, Obesity, Dyslipidemias
- Keywords
- exercise intervention, type 2 diabetes prevention, type 2 diabetes treatment, prediabetes, behavioural intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | Other | Behavioral: Exercise interventionSubjects with type 2 diabetes, diagnosed within the last 3-5 years, treated with metformin only as an anti-diabetic drug |
| Prediabetes | Other | Behavioral: Exercise interventionSubjects with prediabetes, defined as impaired fasting glucose or/and impaired glucose tolerance |
| Normoglycemia | Other | Behavioral: Exercise interventionSubjects with normal fasting glucose and normal glucose tolerance |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 35-65 years old
- BMI: 25-35 kg/m2
- Male gender
- Ability of performing exercise trainings
- Sedentary lifestyle
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionSupervised exercise intervention composed of mixed aerobic and strength activities, with the frequency of 3 sessions per week for 12 weeks, for a total number of trainings of 36. | Behavioural | Normoglycemia, Prediabetes, Type 2 Diabetes |
Primary outcome
HbA1c
Time frame: Three months
Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
Fasting glucose
Time frame: Three months
Fasting glucose concentration measured in plasma using the colorimetric method
2-hour glucose
Time frame: Three months
Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method
Fasting insulin
Time frame: Three months
Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Lean body mass
Time frame: Three months
Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Fat mass
Time frame: Three months
Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Visceral Adipose Tissue mass
Time frame: Three months
Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Weight
Time frame: Three months
Total body weight measured using standardized scale
HOMA-IR
Time frame: Three months
Homeostatic model assessment for insulin resistance
HOMA-beta
Time frame: Three months
Homeostatic model assessment of beta cell function
VO2max
Time frame: Three months
Maximal oxygen consumption measured during cardio-pulmonary exercise test on treadmill
Triglycerides (TG)
Time frame: Three months
Serum triglycerides concentration measured using colorimetric method
High-density lipoprotein cholesterol (HDL)
Time frame: Three months
Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method
Low-density lipoprotein cholesterol (LDL)
Time frame: Three months
Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Total cholesterol
Time frame: Three months
Serum total cholesterol concentration measured using colorimetric method
5 secondary outcomes
Plasma metabolome
Time frame: Three months
Skeletal muscle metabolome
Time frame: Three months
Subcutaneous adipose tissue metabolome
Time frame: Three months
Skeletal muscle transcriptome
Time frame: Three months
Subcutaneous adipose tissue transcriptome
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Type 2 Diabetes and PreDiabetes, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Three months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.