Exercise during mild hypoxia exposure to reverse impaired glucose metabolism in overweight and obese humans
- Conditions
- adult-onset diabetestype 2 diabetes mellitus10018424
- Registration Number
- NL-OMON49775
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
Male subjects between the age of 30-70 years have to be overweight or obese
(BMI ><= 28 kg/m2), with impaired glucose homeostasis determined by OGTT (2h
glucose: >7.8 * 11.1 mmol/L and/or fasting glucose 5.6 - 6.9 mmol/L). In
addition, subjects have to be weight-stable for at least 3 months prior to
participation (no change in bodyweight: <3kg change).
Subjects will be excluded from participation when one or more of the following
aspects are present: cardiovascular disease (determined by questionnaire, 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)) and an electrocardiogram (ECG)), type 2 diabetes
mellitus, cancer, asthma, bronchitis, chronic obstructive pulmonary disease
(COPD), lung fibrosis, obstructive sleep apnea (OSAS), use of oxygen at home
situation, resting SpO2 *93%, abnormal pre-bronchodilator forced expiratory
volume (FEV1) and forced vital capacity (FVC) (based on spirometry), 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 5 years,
the life expectancy will be estimated by the investigator) diagnosis, lactose
intolerance, 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, *-carotene; a standard multi-vitamin capsule is
permitted if less than 800*g/day Vit A, 60mg/day Vit C, 10mg/day Vit E and
400*g/day *-carotene) or use of any medication that influences glucose
metabolism and inflammation. Furthermore, shift-workers will be excluded from
participation as well.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Average 24h glucose concentration (at day 4)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Glycemic variability over 24 hours<br /><br>Time in hyper/hypoglycaemia<br /><br>Energy expenditure<br /><br>Substrate oxidation<br /><br>Fasting and postprandial plasma metabolites<br /><br>Systemic inflammatory markers<br /><br>Blood pressure<br /><br>HOMA-IR<br /><br>Gene/Protein expression (i.e. metabolic/inflammatory parameters) in skeletal<br /><br>muscle tissue</p><br>