NCT Number: NCT05094505
The purpose of this study is to determine the effects of isolated chronic exercise in hypoxia and combined exercise in hypoxia with a low carbohydrate diet on hypoxia-induced transcription factor (HIF1-α); glycaemic control and cardiovascular risk factors in patients with type 2 diabetes.
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Notify MeUp to 75 year
All sexes
Interventional
Not applicable
University of Maia, Porto, Portugal
At baseline, diet plans will be individualized and energy-content prescriptions will be constant throughout the study to maintain the isocaloric control between diets. The planned macronutrient compositions will be, 30% of energy from carbohydrates, 20% from protein and 50% from fat for low carbohydrate diet (LCD) and 30% of energy from fat, 20% from protein and 50% from carbohydrates for the low-fat diet (control diet), during the 8 weeks. Both diets emphasis on low-glycemic index foods and limited saturated fat to 10% of energy, and calculated with appropriate software.
Exercise in hypoxia (at 3000m altitude, 3 sessions/week) will occur during a 8-week period intervention and all testing sessions carried out in a hypoxic chamber at Exercise Medical Center, Porto - Portugal. This chamber allows control of O2 (11-20.97%), temperature (until 50ºC), humidity (until 80%) and altitude (until 8000m). Exercise in hypoxia sessions will consist in 60 min on an ergometer (Excalibur, Lode, Netherlands) of continuous moderate and high intensity interval training, these latter considered as an efficient strategy to improve cardiorespiratory and metabolic health in patients with type 2 diabetes. Loads will be quantified according to pre-intervention testing assessments and controlled throughout each training session. All exercise testing and training sessions will be carried out at the same time of day (± 2 hours) and visits will be separated by at least 48h of recovery.
Height will be measured with use of a stadiometer (SECA), waist circumference was measured by using a tape measure positioned 3 cm above the iliac crest. Body mass index (BMI), weight, fat mass (FM) and fat-free mass (FFM) were determined by using whole-body dual-energy X-ray absorptiometry (Lunar Prodigy; General Electric Corp.). Blood pressure will be measured by using an automated sphygmomanometer (Dinamap Pro; Medical Systems,Tampa, FL) and haematological adaptations will be measured by collecting a venous blood sample from a vein in the arm using a needle. A total of 3 blood samples (pre, 1h post first intervention testing and 48h post the last intervention testing) will be taken.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exercise at sea level, 3 sessions per week, during a 8-week period intervention and will consist in 60 min on an ergometer, of continuous moderate and high intensity interval training. . All exercise testing and training sessions will be carried out at the same time of day (± 2 hours) and visits will be separated by at least 48h of recovery.
Control diet: diet plans will be individualized and energy-content prescriptions will be constant throughout the study to maintain the isocaloric control between diets. The planned macronutrient compositions will be 20% of energy from fat, 20% from protein and 60% from carbohydrates for the low-fat diet during the 8 weeks. Diets emphasis on low-glycemic index foods and limited saturated fat to 10% of energy. Participants will meet individually with a dietitian two times for 8 weeks and should start the dietary intervention along with the intervention with exercise.
Exercise at 3000m altitude, 3 sessions per week, during a 8-week period intervention and will consist in 60 min on an ergometer, of continuous moderate and high intensity interval training. . All exercise testing and training sessions will be carried out at the same time of day (± 2 hours) and visits will be separated by at least 48h of recovery.
Low carbohydrate diet: diet plans will be individualized and energy-content prescriptions will be constant throughout the study to maintain the isocaloric control between diets. The planned macronutrient compositions will be 40% of energy from fat, 20% from protein and 40% from carbohydrates for the low-fat diet during the 8 weeks. Diets emphasis on low-glycemic index foods and limited saturated fat to 10% of energy. Participants will meet individually with a dietitian two times for 8 weeks and should start the dietary intervention along with the intervention with exercise.
Time frame: Baseline and week 8
A venous blood sample from the arm will be collected and glycated hemoglobin will be measured and expressed in mmol/mol and as a percentage (%).
Time frame: Baseline and week 8
A venous blood sample from the arm will be collected and fasting blood glucose (mg/dL) and fasting blood insulin (micro international unit/dL) will be measured, which will determine the homeostasis model assessment (mmol/dL) and homeostasis model assessment 2 for β-cell function (%).
Time frame: Baseline and week 8
A venous blood sample from the arm will be collected and, serum Hypoxia Inducible Factor 1 alpha (HIF1-α) will be measured using specific ELISA kit instructions.
Time frame: Baseline and week 8
A venous blood sample from the arm will be collected and C-Reactive Protein will be measured and expressed in mg/L.
Time frame: Baseline and week 8
Minute ventilation, oxygen uptake, carbon dioxide production and oxygen saturation, in mL/min, will be measured using the new telemetric portable gas analyser K5 (Rome, Italy), which will be connected to the participants through a traditional facemask and will be calibrated according to manufacturing setting.
Time frame: Baseline and week 8
Fat mass (FM) and fat-free mass (FFM) were determined by using whole-body dual-energy X-ray absorptiometry (Lunar Prodigy; General Electric Corp.).
Time frame: Baseline and week 8
Height (in meters) will be measured with use of a stadiometer (SECA) and weight (in kilograms) will be measured by using whole-body dual-energy X-ray absorptiometry (Lunar Prodigy; General Electric Corp.), which will determine the BMI, in kg/m^2.
Time frame: Baseline and week 8
Waist circumference will be measured by using a tape measure (centimeters) positioned 3 centimeters above the iliac crest.
Time frame: Baseline and week 8
Systolic, diastolic, and mean blood pressure will be measured using an automated sphygmomanometer (Dinamap Pro; Medical Systems, Tampa, FL).
Time frame: Baseline and week 8
A venous blood sample from the arm will be collected and total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides will be measured and expressed mg/dL.
Universidade do Porto
Other
Isolated and Combined Effect of a Low Carbohydrate Diet and Chronic Exercise Exposure to Hypoxia on Glycaemic Control and Cardiovascular Risk Factors in Patients With Type 2 Diabetes
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