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

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ClinicalTrials.gov Identifier: NCT05094505
Recruitment Status : Not yet recruiting
First Posted : October 26, 2021
Last Update Posted : October 29, 2021
Sponsor:
Collaborators:
Fundação para a Ciência e a Tecnologia
University Institute of Maia
Information provided by (Responsible Party):
Raquel Kindlovits, Universidade do Porto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carbohydrate Hypoxia Exercise Diabetes Mellitus, Type 2 Other: Exercise in normoxia Other: Control diet Other: Exercise in hypoxia Other: Low carbohydrate diet Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : October 30, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CONTROL GROUP
Exercise at sea level, normoxia. Control diet.
Other: Exercise in normoxia
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.

Other: Control diet
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 30% of energy from fat, 20% from protein and 50% 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.

Experimental: Ex. Hyp. GROUP
Exercise in hypoxia at 3000m altitude. Control diet.
Other: Control diet
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 30% of energy from fat, 20% from protein and 50% 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.

Other: Exercise in hypoxia
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.

Experimental: Ex. Hyp. + LCD GROUP
Exercise in hypoxia at 3000m altitude. Low carbohydrate diet.
Other: Exercise in hypoxia
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.

Other: Low carbohydrate diet
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 50% of energy from fat, 20% from protein and 30% 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.




Primary Outcome Measures :
  1. Changes from pre- to pos intervention in angiogenesis [ 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.


Secondary Outcome Measures :
  1. Changes from pre- to post intervention in insulin resistance index and β-cell capacity [ 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 (%).

  2. Changes from pre- to pos intervention on glycated haemoglobin [ 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 (%).


Other Outcome Measures:
  1. Changes from pre- to pos intervention on cardiovascular risk factor [ 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.

  2. Changes from pre- to pos intervention respiratory and pulmonary gas-exchange variables [ 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.

  3. Changes from pre- to pos intervention on body composition [ 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.).

  4. Changes from pre- to pos intervention on body mass index (BMI) [ 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.

  5. Changes from pre- to pos intervention on waist circumference [ Time Frame: Baseline and week 8 ]
    Waist circumference will be measured by using a tape measure (centimeters) positioned 3 centimeters above the iliac crest.

  6. Changes from pre- to pos intervention on blood pressure [ 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).

  7. Changes from pre- to pos intervention on lipid profile [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05094505


Contacts
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Contact: Raquel Kindlovits, Master +351913679602 raquelkindlovits@id.uff.br
Contact: Vitor Hugo Teixeira, Professor +351225074320 vhugoteixeira@fcna.up.pt

Locations
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Portugal
University of Porto
Porto, Portugal, 4150-180
Contact: Raquel Kindlovits, Master    +351913679602    raquelkindlovits@id.uff.br   
Contact: Vitor Hugo Teixeira, Professor    +351225074320    vhugoteixeira@fcna.up.pt   
University of Maia
Porto, Portugal, 4475-690
Contact: Raquel Kindlovits, Master    +351913679602    raquelkindlovits@id.uff.br   
Contact: João Luís Viana, Professor    +351229866070    jviana@ismai.pt   
Sponsors and Collaborators
Universidade do Porto
Fundação para a Ciência e a Tecnologia
University Institute of Maia
Publications:

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Responsible Party: Raquel Kindlovits, PhD student, Universidade do Porto
ClinicalTrials.gov Identifier: NCT05094505    
Other Study ID Numbers: BD2020.06520
First Posted: October 26, 2021    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoxia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms, Respiratory