Isolated and Combined Effect of a Low Carbohydrate Diet and Exercise in Hypoxia in Patients With Type 2 Diabetes
NCT ID: NCT05094505
Last Updated: 2023-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
42 participants
INTERVENTIONAL
2021-10-01
2023-07-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparing Moderate and High-intensity Interval Training Protocols on Biomarkers in Type 2 Diabetes Patients
NCT03144505
Effect of Acute Exercise on Endothelial Function in Patients With Type 1 Diabetes.
NCT01899872
Effects of Resistance Exercise on Blood Glucose in Post-menopausal Women With Type 1 Diabetes
NCT05203640
Hypoxic Exercise and Glucose Metabolism
NCT04280991
Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes
NCT05362071
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CONTROL GROUP
Exercise at sea level, normoxia. Control diet.
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.
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 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.
Ex. Hyp. GROUP
Exercise in hypoxia at 3000m altitude. Control diet.
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 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 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.
Ex. Hyp. + LCD GROUP
Exercise in hypoxia at 3000m altitude. Low carbohydrate diet.
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.
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 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 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 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.
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 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundação para a Ciência e a Tecnologia
OTHER
University Institute of Maia
OTHER
Universidade do Porto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Raquel Kindlovits
PhD student
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Porto
Porto, , Portugal
University of Maia
Porto, , Portugal
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Evert AB, Boucher JL, Cypress M, Dunbar SA, Franz MJ, Mayer-Davis EJ, Neumiller JJ, Nwankwo R, Verdi CL, Urbanski P, Yancy WS Jr. Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care. 2014 Jan;37 Suppl 1:S120-43. doi: 10.2337/dc14-S120. No abstract available.
Miyashita Y, Koide N, Ohtsuka M, Ozaki H, Itoh Y, Oyama T, Uetake T, Ariga K, Shirai K. Beneficial effect of low carbohydrate in low calorie diets on visceral fat reduction in type 2 diabetic patients with obesity. Diabetes Res Clin Pract. 2004 Sep;65(3):235-41. doi: 10.1016/j.diabres.2004.01.008.
Elhayany A, Lustman A, Abel R, Attal-Singer J, Vinker S. A low carbohydrate Mediterranean diet improves cardiovascular risk factors and diabetes control among overweight patients with type 2 diabetes mellitus: a 1-year prospective randomized intervention study. Diabetes Obes Metab. 2010 Mar;12(3):204-9. doi: 10.1111/j.1463-1326.2009.01151.x.
Davis NJ, Tomuta N, Schechter C, Isasi CR, Segal-Isaacson CJ, Stein D, Zonszein J, Wylie-Rosett J. Comparative study of the effects of a 1-year dietary intervention of a low-carbohydrate diet versus a low-fat diet on weight and glycemic control in type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1147-52. doi: 10.2337/dc08-2108. Epub 2009 Apr 14.
Kirk JK, Graves DE, Craven TE, Lipkin EW, Austin M, Margolis KL. Restricted-carbohydrate diets in patients with type 2 diabetes: a meta-analysis. J Am Diet Assoc. 2008 Jan;108(1):91-100. doi: 10.1016/j.jada.2007.10.003.
Millet GP, Debevec T, Brocherie F, Malatesta D, Girard O. Therapeutic Use of Exercising in Hypoxia: Promises and Limitations. Front Physiol. 2016 Jun 10;7:224. doi: 10.3389/fphys.2016.00224. eCollection 2016. No abstract available.
Haider T, Casucci G, Linser T, Faulhaber M, Gatterer H, Ott G, Linser A, Ehrenbourg I, Tkatchouk E, Burtscher M, Bernardi L. Interval hypoxic training improves autonomic cardiovascular and respiratory control in patients with mild chronic obstructive pulmonary disease. J Hypertens. 2009 Aug;27(8):1648-54. doi: 10.1097/HJH.0b013e32832c0018.
Burtscher M, Pachinger O, Ehrenbourg I, Mitterbauer G, Faulhaber M, Puhringer R, Tkatchouk E. Intermittent hypoxia increases exercise tolerance in elderly men with and without coronary artery disease. Int J Cardiol. 2004 Aug;96(2):247-54. doi: 10.1016/j.ijcard.2003.07.021.
Urdampilleta A, Gonzalez-Muniesa P, Portillo MP, Martinez JA. Usefulness of combining intermittent hypoxia and physical exercise in the treatment of obesity. J Physiol Biochem. 2012 Jun;68(2):289-304. doi: 10.1007/s13105-011-0115-1. Epub 2011 Nov 3.
Faramoushi M, Amir Sasan R, Sari Sarraf V, Karimi P. Cardiac fibrosis and down regulation of GLUT4 in experimental diabetic cardiomyopathy are ameliorated by chronic exposures to intermittent altitude. J Cardiovasc Thorac Res. 2016;8(1):26-33. doi: 10.15171/jcvtr.2016.05. Epub 2016 Mar 14.
Little JP, Gillen JB, Percival ME, Safdar A, Tarnopolsky MA, Punthakee Z, Jung ME, Gibala MJ. Low-volume high-intensity interval training reduces hyperglycemia and increases muscle mitochondrial capacity in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Dec;111(6):1554-60. doi: 10.1152/japplphysiol.00921.2011. Epub 2011 Aug 25.
Wolever TM. Carbohydrate and the regulation of blood glucose and metabolism. Nutr Rev. 2003 May;61(5 Pt 2):S40-8. doi: 10.1301/nr.2003.may.S40-S48.
Sousa A, Figueiredo P, Zamparo P, Pyne DB, Vilas-Boas JP, Fernandes RJ. Exercise Modality Effect on Bioenergetical Performance at V O2max Intensity. Med Sci Sports Exerc. 2015 Aug;47(8):1705-13. doi: 10.1249/MSS.0000000000000580.
Kindlovits R, Sousa AC, Viana JL, Milheiro J, Oliveira BMPM, Marques F, Santos A, Teixeira VH. Evaluating the Therapeutic Potential of Exercise in Hypoxia and Low-Carbohydrate, High-Fat Diet in Managing Hypertension in Elderly Type 2 Diabetes Patients: A Novel Intervention Approach. Nutrients. 2025 Jan 30;17(3):522. doi: 10.3390/nu17030522.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BD2020.06520
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.