Status:
COMPLETED
Hypoxic Exercise and Glucose Metabolism
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Obesity
Insulin Resistance
Eligibility:
MALE
30-70 years
Phase:
NA
Brief Summary
The obesity epidemic calls for new therapeutic opportunities to prevent and treat obesity and its comorbidities amongst which are insulin resistance and cardiovascular diseases. Recent evidence sugges...
Detailed Description
In the present randomized, single-blind, placebo-controlled cross-over study, subjects will be exposed to normobaric 1) mild hypoxia (oxygen level: 15%) and 2) normoxia (oxygen level: 21%) during exer...
Eligibility Criteria
Inclusion
- overweight or obese (BMI \>28 kg/m2)
- impaired glucose tolerance (2h glucose: \>7.8 - 11.1 mmol/L)
- subjects have to be weight-stable for at least 3 months prior to participation (no change in bodyweight: \<3kg change)
Exclusion
- cardiovascular disease (determined by questionnaire, blood pressure (Subjects with moderate to severe hypertension (grade 2 or 3 based on WHO criteria)
- type 2 diabetes mellitus
- cancer
- asthma
- bronchitis
- chronic obstructive pulmonary disease
- lung fibrosis
- obstructive sleep apnea
- use of oxygen at home situation
- resting SpO2 ≤93%
- abnormal pre-bronchodilator forced expiratory volume (FEV1) and forced vital capacity (FVC)
- liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively)
- disease with a life expectancy shorter then 5 years
- 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)
- use of high doses of anti-oxidant vitamins
- use of any medication that influences glucose metabolism and inflammation
- shift working
Key Trial Info
Start Date :
July 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04280991
Start Date
July 22 2019
End Date
December 18 2020
Last Update
November 1 2021
Active Locations (1)
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1
Department of Human Biology, Maastricht University Medical Centre
Maastricht, Netherlands, 6200MD