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The effects of hypoxia and hyperoxia on insulin resistance.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Type 2 diabetes, Obesity
Date of first enrollment	26/05/2025
Target sample size	14
Countries of recruitment
Study type	Interventional
Intervention(s)	In this study, a 30-minute exposure to an 18% oxygen environment (created using an oxygen blender with air and nitrogen) and a 30-minute exposure to a 25% oxygen environment (created using an oxygen blender with air and oxygen) will be utilized.

Outcome(s)

Primary Outcome

Part A [Primary Outcome Measure] SpO2 levels during and after hypoxia and hyperoxia therapy. Part B [Primary Outcome Measure] Change in HOMA-IR (insulin resistance index) before and after hypoxia and hyperoxia therapy.

Secondary Outcome

Part A [Key Secondary Outcome Measures] Change in HOMA-IR (insulin resistance index) between pre-treatment and after hypoxia, as well as between pre-treatment and after hypoxia + hyperoxia. Change in CPR-IR before and after hypoxia and hyperoxia therapy. [Secondary Outcome Measures] Changes in indicators related to glycemic control (fasting blood glucose, fasting insulin, fasting C-peptide, HbA1c, and glycoalbumin). Changes in stress hormones (cortisol, ACTH, blood catecholamine fractions, and metanephrine fractions). Correlation between HOMA-IR and key secondary outcome measures as well as other secondary outcome measures. Safety (adverse events, clinical laboratory values, and vital signs). Part B [Key Secondary Outcome Measure] Change in CPR-IR before and after hypoxia and hyperoxia therapy. [Secondary Outcome Measures] Changes in indicators related to glycemic control (fasting blood glucose, fasting insulin, fasting C-peptide, HbA1c, and glycoalbumin). Changes in stress hormones (cortisol, ACTH, blood catecholamine fractions, and metanephrine fractions). Correlation between HOMA-IR and key secondary outcome measures as well as other secondary outcome measures. SpO2 levels during and after hypoxia and hyperoxia therapy. Safety (adverse events, clinical laboratory values, and vital signs).

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 65age old
Gender	Both
Include criteria	Inclusion Criteria Part A 1) Males and females aged 20 to 65 years at the time of consent. 2) Non-smokers. 3) Individuals with no abnormalities in subjective symptoms or objective findings during screening tests, deemed healthy by the study physician. 4) HbA1c below 6.0%. 5) BMI below 25.0 kg/m2. Part B 1) Males and females aged 20 to 65 years at the time of onsent. 2) HOMA-IR of 1.6 or higher. 3) Patients with type 2 diabetes or obesity meeting one of the following criteria: (1) Type 2 Diabetes Patients: Diagnosed with type 2 diabetes based on WHO diagnostic criteria, with fasting blood glucose >=100 mg/dL and HbA1c >=6.0% during screening; BMI is not restricted. (2) Obesity Patients: BMI of 25.0 kg/m2 or higher and HbA1c below 6.0%. 4) Non-smokers.
Exclude criteria	Exclusion Criteria Patients meeting any of the following conditions will be excluded from the study: Part A 1) History of drug allergies. 2) Administration of investigational participation in other clinical studies within three months prior to screening. 3) Blood donation within three months prior to screening. 4) Regular drug users or individuals with alcohol dependency. 5) History of mental disorders. 6) Clinically significant abnormalities in electrocardiograms. 7) Individuals with underlying respiratory or cardiovascular diseases and those with concomitant sleep apnea. 8) Pregnant or potentially pregnant women and breastfeeding women. Part B 1) Patients with type 1 diabetes. 2) History of severe ketosis, diabetic coma, or pre-coma within 24 weeks prior. 3) Patients with severe infections, pre- or post-surgery, or severe trauma. 4) Pregnant or potentially pregnant patients and breastfeeding patients. 5) Patients with severe liver dysfunction. 6) Patients with moderate or severe renal dysfunction or those undergoing dialysis for end-stage renal disease. 7) Patients with respiratory dysfunction, chronic respiratory diseases requiring home oxygen therapy, or resting SpO2 <= 95% after 5 minutes of rest, and patients with concomitant sleep apnea. 8) Patients with malignant tumors. 9) Patients using insulin preparations or sulfonylureas, or those scheduled to begin these during the study period. 10) Clinically significant abnormalities in electrocardiograms. 11) Patients deemed unsuitable for study participation by their primary physician for medical reasons. 12) History of drug allergies. 13) Administration of investigational participation in other clinical studies within three months prior to screening. 14) Blood donation within three months prior to screening. 15) Regular drug users or individuals with alcohol dependency. 16) History of mental disorders.