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

NCT05094505 | Completed

• 1 other identifier: BD2020.06520
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Carbohydrate; Hypoxia; Exercise; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Changes from pre- to pos intervention on glycated haemoglobin

  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 (%).

  Baseline and week 8

Secondary Outcomes (2)

• Changes from pre- to post intervention in insulin resistance index and β-cell capacity

  Baseline and week 8

• Changes from pre- to pos intervention in angiogenesis

  Baseline and week 8

Other Outcomes (7)

• Changes from pre- to pos intervention on cardiovascular risk factor

  Baseline and week 8

• Changes from pre- to pos intervention respiratory and pulmonary gas-exchange variables

  Baseline and week 8

• Changes from pre- to pos intervention on body composition

  Baseline and week 8

Study Arms (3)

CONTROL GROUP

ACTIVE COMPARATOR

Exercise at sea level, normoxia. Control diet.

Other: Exercise in normoxia; Other: Control diet

Ex. Hyp. GROUP

EXPERIMENTAL

Exercise in hypoxia at 3000m altitude. Control diet.

Other: Control diet; Other: Exercise in hypoxia

Ex. Hyp. + LCD GROUP

EXPERIMENTAL

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

Other: Exercise in hypoxia; Other: Low carbohydrate diet

Interventions

Exercise in normoxia OTHER

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 GROUP

Control diet OTHER

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.

CONTROL GROUP; Ex. Hyp. GROUP

Exercise in hypoxia OTHER

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; Ex. Hyp. GROUP

Low carbohydrate diet OTHER

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.

Ex. Hyp. + LCD GROUP

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• University Institute of Maia: collaborator

Study Sites (2)

University of Porto

Porto, 4150-180, Portugal

Location

University of Maia

Porto, 4475-690, Portugal

Location

Related Publications (14)

• 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.

  PMID: 24357208 BACKGROUND

• 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.

  PMID: 15331203 BACKGROUND

• 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.

  PMID: 20151996 BACKGROUND

• 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.

  PMID: 19366978 BACKGROUND

• 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.

  PMID: 18155993 BACKGROUND

• 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.

  PMID: 27375500 BACKGROUND

• 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.

  PMID: 19387363 BACKGROUND

• 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.

  PMID: 15262041 BACKGROUND

• 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.

  PMID: 22045452 BACKGROUND

• 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.

  PMID: 27069564 BACKGROUND

• 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.

  PMID: 21868679 BACKGROUND

• 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.

  PMID: 12828191 BACKGROUND

• 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.

  PMID: 25412298 BACKGROUND

• 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.

  PMID: 39940380 DERIVED

MeSH Terms

Conditions

Hypoxia; Motor Activity; Diabetes Mellitus, Type 2

Interventions

Exercise; Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 26, 2021
• Study Start: October 1, 2021
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)