Bialystok Exercise Study in Diabetes

Obesity Clinical Trial

— BESD  

Official title:

Bialystok Exercise Study in Diabetes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04634890
• Other study ID #: R-I- 002/469/2014
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 11, 2016
• Est. completion date: December 20, 2023

Study information

• Verified date: March 2022
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemias
• Glucose Intolerance
• Obesity
• Overweight
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Behavioral:
• Exercise intervention
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.

Locations

Country	Name	City	State
Poland	Clinical Research Centre, Medical University of Bialystok	Bialystok	Podlaskie

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Bialystok	University of Copenhagen

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method	Three months
Primary	Fasting glucose	Fasting glucose concentration measured in plasma using the colorimetric method	Three months
Primary	2-hour glucose	Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method	Three months
Primary	Fasting insulin	Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)	Three months
Primary	Lean body mass	Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)	Three months
Primary	Fat mass	Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)	Three months
Primary	Visceral Adipose Tissue mass	Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)	Three months
Primary	Weight	Total body weight measured using standardized scale	Three months
Primary	HOMA-IR	Homeostatic model assessment for insulin resistance	Three months
Primary	HOMA-beta	Homeostatic model assessment of beta cell function	Three months
Primary	VO2max	Maximal oxygen consumption measured during cardio-pulmonary exercise test on treadmill	Three months
Primary	Triglycerides (TG)	Serum triglycerides concentration measured using colorimetric method	Three months
Primary	High-density lipoprotein cholesterol (HDL)	Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method	Three months
Primary	Low-density lipoprotein cholesterol (LDL)	Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method	Three months
Primary	Total cholesterol	Serum total cholesterol concentration measured using colorimetric method	Three months
Secondary	Plasma metabolome	Changes in plasma metabolites concentrations measured using untargeted metabolomics	Three months
Secondary	Skeletal muscle metabolome	Changes in skeletal muscle metabolites concentrations measured using untargeted metabolomics	Three months
Secondary	Subcutaneous adipose tissue metabolome	Changes in subcutaneous adipose tissue metabolites concentrations measured using untargeted metabolomics	Three months
Secondary	Skeletal muscle transcriptome	Changes in skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics	Three months
Secondary	Subcutaneous adipose tissue transcriptome	Changes in subcutaneous adipose tissue gene and smallRNA expressions measured using untargeted transcriptomics	Three months