Isolated and Combined Effect of a Low Carbohydrate Diet and Exercise in Hypoxia in Patients With Type 2 Diabetes

Universidade do Porto

Status: Completed

Conditions: Hypoxia; Carbohydrate; Diabetes Mellitus, Type 2; Exercise

Treatments: Other: Control diet; Other: Exercise in hypoxia; Other: Exercise in normoxia; Other: Low carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05094505

BD2020.06520

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of type 2 diabetes for at least one year
• Glycosylated haemoglobin less than 10%
• Pharmacological regimen stabilized for at least three months
• Main complications of diabetes tracked and controlled (diabetic retinopathy, diabetic nephropathy, diabetic foot and main factors of cardiovascular risk)
• Previous participation in supervised exercise programs in the last 3 months
• Smoking absence in the last 6 months.

Exclusion criteria

• Diagnosis of type 2 diabetes for less than a year
• Glycosylated haemoglobin above 10%
• Pharmacological regimen less than three months
• Main complications of diabetes (diabetic retinopathy, diabetic nephropathy, diabetic foot and main factors of cardiovascular risk)
• Sedentary participants
• Smoking participants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 3 patient groups

CONTROL GROUP

Active Comparator group

Description:

Exercise at sea level, normoxia. Control diet.

Treatment:

Other: Exercise in normoxia

Other: Control diet

Ex. Hyp. GROUP

Experimental group

Description:

Exercise in hypoxia at 3000m altitude. Control diet.

Treatment:

Other: Control diet

Other: Exercise in hypoxia

Ex. Hyp. + LCD GROUP

Experimental group

Description:

Exercise in hypoxia at 3000m altitude. Low carbohydrate diet.

Treatment:

Other: Exercise in hypoxia

Other: Low carbohydrate diet