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ID
Source
Brief title
Health condition
Obesity, Insulin resistance, Adipose tissue, Skeletal muscle, Inflammation, Metabolism
(in dutch: Obesitas, Insulineresistentie, Vetweefsel, Skeletspier, Ontsteking, Stofwisseling)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peripheral insulin sensitivity
(Glucose infusion rate during the steady-state of the high-step of a two-step hyperinsulinemic-euglycemic clamp)
Secondary outcome
- oxygen saturation (SpO2, %)
- adipose tissue oxygen tension
- skeletal muscle oxygen tension
- hepatic insulin sensitivity
- adipose tissue insulin sensitivity
- energy expenditure
- fat and carbohydrate oxidation
- plasma metabolite levels
- systemic inflammatory markers
- blood pressure and heart rate
- body weight
- hunger and satiety (VAS-scores)
- adipose tissue gene/protein expression
- skeletal muscle gene/protein expression
- ex vivo skeletal muscle mitochondrial function
Background summary
The present study will investigate the effects of mild intermittent hypoxia (FiO2, 15%) as compared to normoxia (FiO2, 21%) exposure for 7 consecutive days on tissue-specific insulin sensitivity, substrate metabolism, oxygen saturation, adipose tissue and skeletal muscle oxygenation, and substrate metabolism in obese men. Underlying mechanisms will also be studied.
Study objective
To investigate the effects of moderate IH exposure for 7 consecutive days on wholebody
and tissue-specific insulin sensitivity, substrate metabolism, adipose tissue and
skeletal muscle mitochondrial function/content and PO2 in obese insulin resistant men
Study design
During and/or after both normoxia and mild intermittent hypoxia exposure for 7 consecutive days (days 1-7), subjects will undergo the following measurements:
1) Measurement of adipose tissue and skeletal muscle pO2 (two-channel optochemical
measurement system), forearm
blood flow (venous occlusion plethysmography) (day 6).
2) A high-fat mixed-meal test to examine fasting and postprandial metabolite concentrations, substrate metabolism (indirect calorimetry) and systemic inflammatory markers (day 7).
3) A two-step hyperinsulinemic-euglycemic clamp with glucose tracer to measure tissue-specific insulin sensitivity (peripheral, hepatic and adipose tissue insulin sensitivity), and
collection of adipose tissue and skeletal muscle biopsies (day 8).
Intervention
Obese male subjects will be exposed to 1) mild intermittent hypoxia (FiO2, 15%) and 2) normoxia (FiO2, 21%) for 7 consecutive days (3 cycles of 2h exposure/d in a normobaric room) in a randomized fashion (computer-generated randomization plan; block size, n=4), separated by a 4 week wash-out period.
G.H. Goossens
NUTRIM School for Nutrition, Toxicology and Metabolism
Department of Human Biology
Maastricht University Medical Centre+
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881314
G.Goossens@hb.unimaas.nl
G.H. Goossens
NUTRIM School for Nutrition, Toxicology and Metabolism
Department of Human Biology
Maastricht University Medical Centre+
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881314
G.Goossens@hb.unimaas.nl
Inclusion criteria
1. Male sex
2. Age 35-65 yrs
3. BMI>28 kg/m2)
4. HOMA-IR >2.2
5. Caucasian
6. Weight-stable for at least 3 months prior to participation (change in bodyweight < 3kg).
Exclusion criteria
1. Cardiovascular disease
2. Type 2 diabetes mellitus
3. Cancer
4. Asthma, bronchitis, obstructive sleep apnea syndrome
5. Liver or kidney malfunction (determined based
6. Disease with a life expectancy shorter then 5 years
7. Alcohol abuse (alcohol consumption > 15
units/week)
8. Smoking
9. Plans to lose weight or to change lifestyle (e.g. to increase physical activity level or change diet)
10. Participation in organized sports activities more than three hours a week
11. Use of high doses of anti-oxidant vitamins
12. Use of any medication that influences study outcomes.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7120 |
NTR-old | NTR7325 |
CCMO | NL54685.068.15 |
OMON | NL-OMON42717 |