Effects of moderate intermittent hypoxia exposure on peripheral insulin sensitivity and substrate metabolism in humans

Effects of moderate intermittent hypoxia exposure on peripheral insulin sensitivity and substrate metabolism in humans - Moderate intermittent hypoxia exposure

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42717

Enrollment

Registered

2015-12-23

Start date

2016-04-18

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

adult-onset diabetes type 2 diabetes mellitus

Interventions

Exposure to 15% O2 is comparable to an altitude of ~2800 m. Adverse Events (e.g. Acute mountain sickness symptoms) may occur above ~2500 m, although most people do not experience symptoms at this al

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Males with overweight/obesity (body mass index >= 28 kg/m2) - insulin resistant (HOMA>=2.2) - Age: 30-65 - Non smoking - A stable bodyweight for at least 3 months (no change in bodyweight:

Exclusion criteria

Exclusion criteria: cardiovascular disease (determined by questionnaire, electrocardiogram (ECG), blood pressure (subjects with moderate to severe hypertension (grade 2 or 3 based on WHO criteria) will be excluded from participation in this study (SBP >160 mmHg, DBP > 100 mmHg)), type 2 diabetes mellitus, cancer, asthma or bronchitis, obstructive sleep apnea (OSAS), liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively), disease with a life expectancy shorter then 5 years (subjects will be asked if they have a disease, which could lead to death within 5yr) diagnosis, abuse of products (alcohol consumption > 15 units/week), smoking, plans to lose weight (subjects will be asked if they have weight loss plans (e.g. to increase their physical activity level or change diet): a positive answer will lead to exclusion) or follow a hypocaloric diet, participation in organized sports activities more than three hours a week, use of high doses of anti-oxidant vitamins (A, C, E, β-carotene; a standard multi-vitamin capsule is permitted if less than 800µg/day Vit A, 60mg/day Vit C, 10mg/day Vit E and 400µg/day β-carotene) or use of any medication that influences glucose metabolism and inflammation

Design outcomes

Primary

Measure	Time frame
- peripheral insulin sensitivity	—

Secondary

Measure	Time frame
- adipose tissue and skeletal muscle oxygen tension - hepatic insulin sensitivity - body weight - Body Mass Index (BMI) - body composition (DEXA) - adipose tissue blood flow - plasma glucose, insulin, free fatty acids, triacylglycerol, glycerol concentrations - blood pressure - blood oxygen saturation - hunger and satiety - energy expenditure and substrate oxidation - systemic inflammation (e.g. IL-6, leptin, adiponectin, TNFa) - gene expression in adipose tissue and skeletal muscle - fat cell size - adipose tissue and skeletal muscle oxidative capacity - Glucose uptake by adipocytes and myotubes	—

Measure

Time frame

- adipose tissue and skeletal muscle oxygen tension - hepatic insulin sensitivity - body weight - Body Mass Index (BMI) - body composition (DEXA) - adipose tissue blood flow - plasma glucose, insulin, free fatty acids, triacylglycerol, glycerol concentrations - blood pressure - blood oxygen saturation - hunger and satiety - energy expenditure and substrate oxidation - systemic inflammation (e.g. IL-6, leptin, adiponectin, TNFa) - gene expression in adipose tissue and skeletal muscle - fat cell size - adipose tissue and skeletal muscle oxidative capacity - Glucose uptake by adipocytes and myotubes

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)