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Bialystok Exercise Study in Diabetes (BESD)

Primary Purpose

Type 2 Diabetes, PreDiabetes, Overweight

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Exercise intervention
Sponsored by
Medical University of Bialystok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring exercise intervention, type 2 diabetes prevention, type 2 diabetes treatment, prediabetes, behavioural intervention

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • Clinical Research Centre, Medical University of Bialystok

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Type 2 Diabetes

Prediabetes

Normoglycemia

Arm Description

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

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

Subjects with normal fasting glucose and normal glucose tolerance

Outcomes

Primary Outcome Measures

HbA1c
Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
Fasting glucose
Fasting glucose concentration measured in plasma using the colorimetric method
2-hour glucose
Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method
Fasting insulin
Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Lean body mass
Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Fat mass
Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Visceral Adipose Tissue mass
Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Weight
Total body weight measured using standardized scale
HOMA-IR
Homeostatic model assessment for insulin resistance
HOMA-beta
Homeostatic model assessment of beta cell function
VO2max
Maximal oxygen consumption measured during cardio-pulmonary exercise test on treadmill
Triglycerides (TG)
Serum triglycerides concentration measured using colorimetric method
High-density lipoprotein cholesterol (HDL)
Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method
Low-density lipoprotein cholesterol (LDL)
Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Total cholesterol
Serum total cholesterol concentration measured using colorimetric method

Secondary Outcome Measures

Plasma metabolome
Changes in plasma metabolites concentrations measured using untargeted metabolomics
Skeletal muscle metabolome
Changes in skeletal muscle metabolites concentrations measured using untargeted metabolomics
Subcutaneous adipose tissue metabolome
Changes in subcutaneous adipose tissue metabolites concentrations measured using untargeted metabolomics
Skeletal muscle transcriptome
Changes in skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
Subcutaneous adipose tissue transcriptome
Changes in subcutaneous adipose tissue gene and smallRNA expressions measured using untargeted transcriptomics

Full Information

First Posted
November 12, 2020
Last Updated
January 23, 2023
Sponsor
Medical University of Bialystok
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT04634890
Brief Title
Bialystok Exercise Study in Diabetes
Acronym
BESD
Official Title
Bialystok Exercise Study in Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 11, 2016 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Bialystok
Collaborators
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, PreDiabetes, Overweight, Obesity, Dyslipidemias
Keywords
exercise intervention, type 2 diabetes prevention, type 2 diabetes treatment, prediabetes, behavioural intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Type 2 Diabetes
Arm Type
Other
Arm Description
Subjects with type 2 diabetes, diagnosed within the last 3-5 years, treated with metformin only as an anti-diabetic drug
Arm Title
Prediabetes
Arm Type
Other
Arm Description
Subjects with prediabetes, defined as impaired fasting glucose or/and impaired glucose tolerance
Arm Title
Normoglycemia
Arm Type
Other
Arm Description
Subjects with normal fasting glucose and normal glucose tolerance
Intervention Type
Behavioral
Intervention Name(s)
Exercise intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c
Description
Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
Time Frame
Three months
Title
Fasting glucose
Description
Fasting glucose concentration measured in plasma using the colorimetric method
Time Frame
Three months
Title
2-hour glucose
Description
Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method
Time Frame
Three months
Title
Fasting insulin
Description
Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Time Frame
Three months
Title
Lean body mass
Description
Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Time Frame
Three months
Title
Fat mass
Description
Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Time Frame
Three months
Title
Visceral Adipose Tissue mass
Description
Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Time Frame
Three months
Title
Weight
Description
Total body weight measured using standardized scale
Time Frame
Three months
Title
HOMA-IR
Description
Homeostatic model assessment for insulin resistance
Time Frame
Three months
Title
HOMA-beta
Description
Homeostatic model assessment of beta cell function
Time Frame
Three months
Title
VO2max
Description
Maximal oxygen consumption measured during cardio-pulmonary exercise test on treadmill
Time Frame
Three months
Title
Triglycerides (TG)
Description
Serum triglycerides concentration measured using colorimetric method
Time Frame
Three months
Title
High-density lipoprotein cholesterol (HDL)
Description
Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method
Time Frame
Three months
Title
Low-density lipoprotein cholesterol (LDL)
Description
Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Time Frame
Three months
Title
Total cholesterol
Description
Serum total cholesterol concentration measured using colorimetric method
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Plasma metabolome
Description
Changes in plasma metabolites concentrations measured using untargeted metabolomics
Time Frame
Three months
Title
Skeletal muscle metabolome
Description
Changes in skeletal muscle metabolites concentrations measured using untargeted metabolomics
Time Frame
Three months
Title
Subcutaneous adipose tissue metabolome
Description
Changes in subcutaneous adipose tissue metabolites concentrations measured using untargeted metabolomics
Time Frame
Three months
Title
Skeletal muscle transcriptome
Description
Changes in skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
Time Frame
Three months
Title
Subcutaneous adipose tissue transcriptome
Description
Changes in subcutaneous adipose tissue gene and smallRNA expressions measured using untargeted transcriptomics
Time Frame
Three months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Clinical Research Centre, Medical University of Bialystok
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-276
Country
Poland

12. IPD Sharing Statement

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Bialystok Exercise Study in Diabetes

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