Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Impaired Glucose Tolerance in Obese
  • Insulin Resistance
  • Obesity
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

Age
Between 30 years and 70 years
Gender
Only males

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 exercise (2 x 30min/day on a cycle ergometer) of the same relative exercise intensity (equal to 50%WMAX ...

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 exercise (2 x 30min/day on a cycle ergometer) of the same relative exercise intensity (equal to 50%WMAX under normoxic conditions) for 4 consecutive days. Subjects will be randomly assigned to each condition (computer-generated randomization plan; block size, n=4), separated by a washout period (3-6 weeks). To accomplish this, subjects will exercise in an oxygen chamber in which oxygen concentration of the ambient air and, as such, oxygen levels can be tightly controlled and monitored. Subjects will cycle two times a day for 30 minutes at 50% WMAX, determined by an incremental workload test. Since we will allow 5-10 min for subjects to get ready to start the 30-min exercise session, and take into account a 5-min cooling down period before leaving the hypoxic room again, subjects will be in the room for 45 min for each session. After initial screening, subjects are asked to visit the university for two periods of 5 consecutive days each with a washout period of 3-6 weeks. During the first 4 days (time investment: 4.5 hours/day), subjects will be undergoing the exercise regimen, as described above. At day 1, on the first morning of each regimen, a glucose sensor (Enlite Glucose Sensor MiniMed; Medtronic). The sensor will be inserted subcutaneously, will be inserted subcutaneously, at 5 cm from the umbilicus, on the right side of the abdomen, and will be connected to a continuous glucose monitor (iPro2 Professional CGM MiniMed; Medtronic, Northridge, CA, USA). The sensor will remain inserted throughout the study (days 1-5). Furthermore, a physical activity monitor (ActivPAL3 micro monitor) will be applied at the same moment, to monitor physical activity of participants. At the end of day 5, the glucose sensor, and the physical activity monitor will be removed. At days 1-5 (time investment: 4.5 hours), fasting blood samples will be collected to determine plasma metabolites and inflammatory markers, and blood pressure and body weight will be monitored. At day 5 (time investment: 8 hours), a mixed liquid meal challenge will be performed to determine fasting and postprandial metabolite concentrations, and substrate oxidation (using indirect calorimetry). A skeletal muscle biopsy (m. vastus lateralis) will be collected under fasting conditions. Moreover, HOMA-IR will be used to estimate insulin resistance, using fasting plasma glucose and insulin values measured on the day after completion of the 4 day regimen. After initial screening, the assessment of basal metabolic rate (BMR) and the incremental workload test (to determine the maximal workload, WMAX), subjects will have to invest approximately 52 hours.

Tracking Information

NCT #
NCT04280991
Collaborators
Not Provided
Investigators
Not Provided