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Recruiting NCT07073326

Effects of Normobaric Hypoxic Training in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

No phase Interventional MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Normobaric Hypoxia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HYPOTRAIN, NORMOTRAIN.
Who it may be relevant to
Registry conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Normobaric Hypoxia. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Normobaric Hypoxia Aerobic Training in People With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Overview

Altitude training has been suggested to be of potential support to improve some chronic clinical conditions, especially metabolic conditions. Normobaric hypoxia represents a promising system to simulate altitude training, and its efficacy and safety have been suggested in different conditions, including diabetes, obesity and hypertension. Metabolic dysfunction-associated steatotic liver disease (MASLD) can characterized by metabolic alterations (including altered body composition, lipid and glycemic profile, etc.), and might benefit from aerobic training performed in simulated altitude training (i.e., normobaric hypoxia). Mild altitude training will be proposed (equal to about 2'500 m, 15% FiO2) and compared to a sham normobaric normoxia condition, during an 8-week 3 or 2 times per week 1-h aerobic training (walking) at 60-65% of maximum heart rate (HRmax). Cardiorespiratory fitness, body composition, and metabolic profile will be investigated.

Interventions

  • Other HYPOTRAIN
    8 weeks of 2/3 times per week, 1-h aerobic training (walking on a treadmill at 60-65% HRmax) while wearing a mask and air is delivered between 15 and 16 FiO2%
  • Other NORMOTRAIN
    8 weeks of 2/3 times per week, 1-h aerobic training (walking on a treadmill at 60-65% HRmax) while wearing a mask and air is delivered between at normal (around 21) FiO2%

Primary outcome measures

  • Body mass (kg) [Time frame: At the beginning of the study and after 8 weeks of training]
  • Fat mass (%) [Time frame: At the beginning of the study and after 8 weeks of training]
Secondary outcome measures (10)
  • Maximum oxygen uptake (mL/kg*min) [Time frame: At the beginning of the study and potentially after 8 weeks of training]
  • Liver markers [Time frame: At the beginning of the study and after 8 weeks of training]
  • Ventilatory threshold (mL/kg*min) [Time frame: At the beginning of the study and potentially after 8 weeks of training]
  • Triglyceride (mg/dL) [Time frame: At the beginning of the study and after 8 weeks of training]
  • Total cholesterol (mg/dL) [Time frame: At the beginning of the study and after 8 weeks of training]
  • High-density lipoprotein (mg/dL) [Time frame: At the beginning of the study and after 8 weeks of training]
  • Low-density lipoprotein (mg/dL) [Time frame: At the beginning of the study and after 8 weeks of training]
  • C-reactive protein (mg/dL) [Time frame: At the beginning of the study and after 8 weeks of training]
  • Glycemia (mg/dL) [Time frame: At the beginning of the study and after 8 weeks of training]
  • Insulinemia (mg/dL) [Time frame: At the beginning of the study and after 8 weeks of training]

Eligibility criteria

Inclusion criteria

  • Being diagnosed with MASLD from at the least 3 years
  • BMI > 26 kg/m2
  • Being sedentary

Exclusion criteria

  • Cardiovascular, respiratory, renal complications
  • Hypertension
  • COPD
  • Previous history of acute mountain sickness or altitude-associated symptoms
  • Females only: pregnancy or breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Italy · 1 center
  • University of Trieste - Exercise Physiology and Kinesiology Lab — Trieste

Publications

  • Luo Y, Chen Q, Zou J, Fan J, Li Y, Luo Z. Chronic Intermittent Hypoxia Exposure Alternative to Exercise Alleviates High-Fat-Diet-Induced Obesity and Fatty Liver. Int J Mol Sci. 2022 May 6;23(9):5209. doi: 10.3390/ijms23095209. PMID 35563600
  • DE Groote E, Britto FA, Bullock L, Francois M, DE Buck C, Nielens H, Deldicque L. Hypoxic Training Improves Normoxic Glucose Tolerance in Adolescents with Obesity. Med Sci Sports Exerc. 2018 Nov;50(11):2200-2208. doi: 10.1249/MSS.0000000000001694. PMID 29923910

Identifiers

NCT: NCT07073326 · DSM_FisioMedSport_Hypoxic25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗