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Exercise and high-altitude exposure as therapy for individuals with type 2 Diabetes Mellitus

Effects of training breathing reduced oxygen air during exercise pauses on hematologic responses, energy metabolism, and physical fitness in individuals with type 2 Diabetes Mellitus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9gmbt9v
Enrollment
Unknown
Registered
2024-08-30
Start date
2024-07-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

This is a randomized, controlled, single-blinded clinical study. Fifty-six individuals with type 2 Diabetes Mellitus will be recruited. Three interventions will be carried out (inter-effort recovery h
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Sponsors

Escola de Educação Física e Esportes de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Escola de Educação Física e Esportes de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: men and women;18 to 59 years old;type 2 diabetes mellitus diagnosis (fasting glucose >126 mg/dL, or >200 mg/dL at any time, or glycated hemoglobin >6.5%) without complications;absence of insulin therapy;presentation of a completed and signed Physical Activity Readiness Questionnaire (PAR-Q);stable weight (changes <3 kg) for at least three months before the study

Exclusion criteria

Exclusion criteria: exposure to altitudes of >1500m in the last three months or during the study;use of insulin therapy during the study;unstable angina;uncontrolled hypertension;lung problems;severe valvular disease;decompensated heart failure;renal failure;neurological and orthopedic problems that prevent physical exercise;surgery scheduled during the study period;less than 87.5% of sessions completed (limit of 3 absences)

Design outcomes

Primary

MeasureTime frame
It is expected to find a 12% reduction in area under curve in a glucose tolerance test, the data will be collected one week before and after the intervention;It is expected to find a 7% reduction in glycated hemoglobin, the data will be collected one week before and after the intervention ;It is expected to find a 7% reduction in blood glucose and fasting insulin, the data will be collected one week before and after the intervention

Secondary

MeasureTime frame
It is expected to find a 5% reduction in the total caloric amount in food consumption measured by a food diary of 3 non-consecutive days, the data will be collected one week before and after the intervention;It is expected to find a 15% increase in resting metabolic rate, measured by indirect calorimetry the data will be collected one week before and after the intervention;It is expected to find a 10% reduction insulin resistance homeostatic model assessment index, the data will be collected one week before and after the intervention ;It is expected to find a 10% increase in cardiorespiratory fitness as oxygen consumption peak in incremental test with cardiorespiratory analysis, the data will be collected one week before and after the intervention ;It is expected a body composition improvement, measured by X-ray absorptiometry technique, with 5% body mass reduction, 5% fat free mass increase, and 10% fat mass reduction, the data will be collected one week before and after the intervention ;Dietary quality maintenance, measured by a food consumption marker questionnaire after 8 weeks of intervention.

Countries

Brazil

Contacts

Public ContactMatheus Firmino

Escola de Educação Física e Esportes de Ribeirão Preto da Universidade de São Paulo (EEFERP-USP)

matheusfirmino@usp.br+55-16-3315-0529

Outcome results

None listed

Source: REBEC (via WHO ICTRP)