ObesityHYTRIMNCT04280991
Hypoxic Exercise and Glucose Metabolism
A study testing Moderate intensity exercise under mild normobaric hypoxia and normoxia in people with Obesity and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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 suggests that tissue oxygenation plays an important role in cardiometabolic health. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Impaired Glucose Tolerance in Obese
- What is being tested?
- Moderate intensity exercise under mild normobaric hypoxia and normoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jul 2019to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Human Biology, Maastricht University Medical Centre
Maastricht, 6200MD
About this study
Official title: Exercise During Mild Hypoxia Exposure to Reverse Impaired Glucose Metabolism in Overweight and Obese Humans
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 suggests that tissue oxygenation plays an important role in cardiometabolic health. Remarkably, individuals residing at high altitude (hypobaric hypoxia) are less prone to develop type 2 diabetes mellitus as compared to individuals living at sea-level (normobaric normoxia). Furthermore, there is evidence to suggest that normobaric hypoxia exposure may improve glucose homeostasis and insulin sensitivity in both rodents and humans.
The level of physical activity is an important determinant of insulin sensitivity and glucose homeostasis. It is well established that performing physical activity improves glucose uptake in the short term, and glycemic control in the long term. Interestingly, recent studies have demonstrated that an acute bout of exercise under hypoxic conditions (inhalation of air containing less oxygen) may lead to a more pronounced improvement in plasma glucose concentrations and/or insulin sensitivity as compared to normoxic exercise. However, the effects of repeated hypoxic exercise bouts on glucose profile throughout the day (i.e. 24h continuous glucose monitoring) remain elusive. In the present randomized, placebo-controlled, single-blind, cross-over study study, the investigators will investigate the effects of exercise under mild normobaric hypoxic conditions (FiO2, 15%) for 4 consecutive days (2 x 30-min cycling session at 50% WMAX) on postprandial substrate metabolism and 24h-glucose level in overweight/obese subjects with impaired glucose tolerance. The investigators hypothesize that 4 consecutive days of exposure to mild hypoxia while performing moderate intensity exercise improves glucose homeostasis in overweight and obese individuals with impaired glucose homeostasis.
Read the 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 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.
- Being tested
- Moderate intensity exercise under mild normobaric hypoxia and normoxia
- Keywords
- Metabolism, Hypoxia, Glucose metabolism
- Medical subject headings
- Obesity, Insulin Resistance, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity exercise under mild normobaric hypoxia and normoxiaOther
The participant will perform the exercise interventions consisting of cycling at the heart rate corresponding with 50%WMAX (normoxia) or heart rate corresponding with 50% WMAX (hypoxia) for 30 minutes, twice a day, for 4 consecutive days. 24h glucose concentration will be monitored continuously.
| Study group | Role | What they receive |
|---|---|---|
| Moderate intensity exercise under mild normobaric hypoxia | Experimental | The participants will perform moderate intensity exercise at heart rate corresponding with 50%WMAX (determined during maximal workload test) under mild normobaric hypoxia (FiO2: 15%), two times 30 minutes per day for 4 consecutive days on a cycle ergometer. 24h glucose concentration will be monitored continuously. Afterwards, a meal test challenge will be performed at day 5 to determine fasting/postprandial substrate oxidation. Receives: Other: Moderate intensity exercise under mild normobaric hypoxia and normoxia |
| Moderate intensity exercise under normoxia | Placebo comparator | The participants will perform moderate intensity exercise at 50% WMAX (determined during maximal workload test) under normoxia (FiO2: 21%) two times 30 minutes per day for 4 consecutive days on a cycle ergometer. 24h glucose concentration will be monitored continuously. Afterwards, a meal test challenge test will be performed at day 5 to determine fasting/postprandial substrate oxidation. Receives: Other: Moderate intensity exercise under mild normobaric hypoxia and normoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average 24 hour glucose concentration (at day 4)
Glucose concentration will be measured in the interstitial fluid of the subcutaneous adipose tissue every 5 min using a glucose sensor (Enlite Glucose Sensor MiniMed; Medtronic) (iPro2 Professional CGM MiniMed; Medtronic, Northridge, CA, USA), which 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 cumulative effects of the 4 day exercise regimens will be determined using the average 24h glucose levels collected on day 4.
Measured: Change of average glucose concentration compared to moderate intensity exercise under normoxia (21% oxygen) at day 4
Secondary outcomes (17)
Glycemic variability over 24 hours
Moderate intensity exercise under mild hypoxia compared to normoxia. The cumulative effects of the 4 day exercise regimens will be determined using the 24h glucose levels collected on day 4. Glycemic variability, which reflects acute glucose fluctuations, will be assessed by the standard deviation of the average 24 h glucose concentration (SD)
Measured: Change of glycemic variability over 24 hours compared to moderate intensity exercise under normoxia (21% oxygen) at day 2, 3, 4 and 5
Time in hyper/hypoglycaemia
Moderate intensity exercise under mild hypoxia compared to normoxia. The cumulative effects of the 4 day exercise regimens will be determined using the 24h glucose levels collected on day 4 frequency and duration of hypo- and hyperinsulinemia will be monitored using the iPro2 device and Enlite Glucose Sensor (Medtronic) and is defined as a glucose level of ≥10.0 mmol/l for hyperglycemia, whilst hypoglycemia will be defined as a glucose concentration ≤3.9 mmol/l.
Measured: Change of time spent in hyper/hypoglycemia compared to moderate intensity exercise under normoxia (21% oxygen) at day 2, 3, 4 and 5
Energy expenditure
Moderate intensity exercise under mild hypoxia compared to normoxia. Energy expenditure will be determined by means of indirect calorimetry at day 5 (under normoxia in both periods), after 4 consecutive days of performing exercise under normoxia or mild hypoxia.
Measured: Change of energy expenditure compared to moderate intensity exercise under normoxia (21% oxygen) at day 5 during the meal-test
Substrate oxidation
Moderate intensity exercise under mild hypoxia compared to normoxia. Substrate oxidation (e.g. carbohydrate and fat oxidation) will be determined by means of indirect calorimetry at day 5 (under normoxia in both periods), after 4 consecutive days of performing exercise under normoxia or mild hypoxia.
Measured: Change of substrate oxidation compared to moderate intensity exercise under normoxia (21% oxygen) at day 5 during the meal-test
Systolic and diastolic blood pressure
Moderate intensity exercise under mild hypoxia compared to normoxia. Every morning, before having breakfast, systolic and diastolic blood pressure will be monitored in mmHg.
Measured: Change of systolic and diastolic blood pressure compared to moderate intensity exercise under normoxia (21% oxygen) at day 1, 2, 3, 4 and 5 under fasting conditions.
HOMA-IR
Moderate intensity exercise under mild hypoxia compared to normoxia. HOMA-IR will be determined from circulating insulin and glucose levels at sampled at day 5.
Measured: Change of HOMA-IR compared to moderate intensity exercise under normoxia (21% oxygen) at day 5 under fasting conditions
Gene/protein expression of AMPK and phosphorylation of AMPK in skeletal muscle tissue
Moderate intensity exercise under mild hypoxia compared to normoxia. Skeletal muscle biopsy will be performed at day 5 under fasting conditions and will be analysed for histology and gene/protein expression. Gene expression will be performed by targeted q-PCR (quantitative-polymerase chain reaction), and protein expression will be performed by means of Western blotting to quantify expression of AMPK.
Measured: Change of gene/protein expression of AMPK in skeletal muscle tissue compared to moderate intensity exercise under normoxia (21% oxygen) at day 5, under fasting conditions, when skeletal muscle biopsy will be collected
Systemic concentration of interleukin-8 (IL-8; inflammatory marker)
Moderate intensity exercise under mild hypoxia compared to normoxia. At day 5, fasting blood will be sampled and analysed for systemic inflammatory markers by means of ELISA
Measured: Change of concentrations of IL-8 compared to moderate intensity exercise under normoxia (21% oxygen) during fasting conditions at day 5
Systemic concentration of tumor necrosis factor alpha (TNF-alpha; inflammatory marker)
Moderate intensity exercise under mild hypoxia compared to normoxia. At day 5, fasting blood will be sampled and analysed for systemic inflammatory markers by means of ELISA
Measured: Change of concentrations of TNF-alpha compared to moderate intensity exercise under normoxia (21% oxygen) during fasting conditions at day 5
Systemic concentration of interferon-gamma (IFN-gamma; inflammatory marker)
Moderate intensity exercise under mild hypoxia compared to normoxia. At day 5, fasting blood will be sampled and analysed for systemic inflammatory markers by means of ELISA
Measured: Change of concentrations of IFN-gamma compared to moderate intensity exercise under normoxia (21% O2) during fasting conditions at day 5
Systemic concentration of interleukin-6 (IL-6; inflammatory marker)
Moderate intensity exercise under mild hypoxia compared to normoxia. At day 5, fasting blood will be sampled and analysed for systemic inflammatory markers by means of ELISA
Measured: Change of concentrations of IL-6 compared to moderate intensity exercise under normoxia (21% oxygen) during fasting conditions at day 5
Fasting and postprandial plasma glucose concentration
Moderate intensity exercise under mild hypoxia compared to normoxia. At day 5, fasting and postprandial circulating glucose concentrations (mmol/L) will be determined during a high-carbohydrate mixed-meal test.
Measured: Change of fasting and postprandial plasma glucose concentrations (mmol/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Fasting and postprandial plasma insulin concentration
Moderate intensity exercise under mild hypoxia compared to normoxia. At day 5, fasting and postprandial circulating insulin concentrations (mU/L) will be determined during a high-carbohydrate mixed-meal test.
Measured: Change of fasting and postprandial plasma insulin concentrations (mU/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Fasting and postprandial plasma free fatty acids concentration
Moderate intensity exercise under mild hypoxia compared to normoxia. At day 5, fasting and postprandial circulating free fatty acids concentrations (μmol/L) will be determined during a high-carbohydrate mixed-meal test.
Measured: Change of fasting and postprandial plasma free fatty acids concentrations (μmol/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Fasting and postprandial plasma glycerol concentration
Moderate intensity exercise under mild hypoxia compared to normoxia. At day 5, fasting and postprandial circulating glycerol (μmol/L) will be determined during a high-carbohydrate mixed-meal test.
Measured: Change of fasting and postprandial plasma glycerol concentrations (μmol/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Fasting and postprandial plasma triglycerides concentration
Moderate intensity exercise under mild hypoxia compared to normoxia. At day 5, fasting and postprandial circulating triglycerides (μmol/L) will be determined during a high-carbohydrate mixed-meal test.
Measured: Change of fasting and postprandial plasma triglycerides concentrations (μmol/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Fasting and postprandial plasma lactate concentration
Moderate intensity exercise under mild hypoxia compared to normoxia. At day 5, fasting and postprandial circulating lactate (mmol/L) will be determined during a high-carbohydrate mixed-meal test.
Measured: Change of fasting and postprandial plasma lactate concentrations (mmol/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start22 Jul 2019
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280991
- Sponsor's protocol ID
- NL68218.068.18 / METC 18-059
- Acronym
- HYTRIM
- Status last verified
- Oct 2021
- First submitted
- 16 Jul 2019
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise During Mild Hypoxia Exposure to Reverse Impaired Glucose Metabolism in Overweight and Obese Humans
- ClinicalTrials.gov ID
- NCT04280991
- Acronym / sponsor ID
- HYTRIM / NL68218.068.18 / METC 18-059
- Keywords
- Metabolism, Hypoxia, Glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 suggests that tissue oxygenation plays an important role in cardiometabolic health. Remarkably, individuals residing at high altitude (hypobaric hypoxia) are less prone to develop type 2 diabetes mellitus as compared to individuals living at sea-level (normobaric normoxia). Furthermore, there is evidence to suggest that normobaric hypoxia exposure may improve glucose homeostasis and insulin sensitivity in both rodents and humans.
The level of physical activity is an important determinant of insulin sensitivity and glucose homeostasis. It is well established that performing physical activity improves glucose uptake in the short term, and glycemic control in the long term. Interestingly, recent studies have demonstrated that an acute bout of exercise under hypoxic conditions (inhalation of air containing less oxygen) may lead to a more pronounced improvement in plasma glucose concentrations and/or insulin sensitivity as compared to normoxic exercise. However, the effects of repeated hypoxic exercise bouts on glucose profile throughout the day (i.e. 24h continuous glucose monitoring) remain elusive. In the present randomized, placebo-controlled, single-blind, cross-over study study, the investigators will investigate the effects of exercise under mild normobaric hypoxic conditions (FiO2, 15%) for 4 consecutive days (2 x 30-min cycling session at 50% WMAX) on postprandial substrate metabolism and 24h-glucose level in overweight/obese subjects with impaired glucose tolerance. The investigators hypothesize that 4 consecutive days of exposure to mild hypoxia while performing moderate intensity exercise improves glucose homeostasis in overweight and obese individuals with impaired glucose homeostasis.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity exercise under mild normobaric hypoxia | Experimental | Other: Moderate intensity exercise under mild normobaric hypoxia and normoxiaThe participants will perform moderate intensity exercise at heart rate corresponding with 50%WMAX (determined during maximal workload test) under mild normobaric hypoxia (FiO2: 15%), two times 30 minutes per day for 4 consecutive days on a cycle ergometer. 24h glucose concentration will be monitored continuously. Afterwards, a meal test challenge will be performed at day 5 to determine fasting/postprandial substrate oxidation. |
| Moderate intensity exercise under normoxia | Placebo comparator | Other: Moderate intensity exercise under mild normobaric hypoxia and normoxiaThe participants will perform moderate intensity exercise at 50% WMAX (determined during maximal workload test) under normoxia (FiO2: 21%) two times 30 minutes per day for 4 consecutive days on a cycle ergometer. 24h glucose concentration will be monitored continuously. Afterwards, a meal test challenge test will be performed at day 5 to determine fasting/postprandial substrate oxidation. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity exercise under mild normobaric hypoxia and normoxiaThe participant will perform the exercise interventions consisting of cycling at the heart rate corresponding with 50%WMAX (normoxia) or heart rate corresponding with 50% WMAX (hypoxia) for 30 minutes, twice a day, for 4 consecutive days. 24h glucose concentration will be monitored continuously. | Other | Moderate intensity exercise under mild normobaric hypoxia, Moderate intensity exercise under normoxia |
Primary outcome
Average 24 hour glucose concentration (at day 4)
Time frame: Change of average glucose concentration compared to moderate intensity exercise under normoxia (21% oxygen) at day 4
Glucose concentration will be measured in the interstitial fluid of the subcutaneous adipose tissue every 5 min using a glucose sensor (Enlite Glucose Sensor MiniMed; Medtronic) (iPro2 Professional CGM MiniMed; Medtronic, Northridge, CA, USA), which 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 cumulative effects of the 4 day exercise regimens will be determined using the average 24h glucose levels collected on day 4.
17 secondary outcomes
Glycemic variability over 24 hours
Time frame: Change of glycemic variability over 24 hours compared to moderate intensity exercise under normoxia (21% oxygen) at day 2, 3, 4 and 5
Time in hyper/hypoglycaemia
Time frame: Change of time spent in hyper/hypoglycemia compared to moderate intensity exercise under normoxia (21% oxygen) at day 2, 3, 4 and 5
Energy expenditure
Time frame: Change of energy expenditure compared to moderate intensity exercise under normoxia (21% oxygen) at day 5 during the meal-test
Substrate oxidation
Time frame: Change of substrate oxidation compared to moderate intensity exercise under normoxia (21% oxygen) at day 5 during the meal-test
Systolic and diastolic blood pressure
Time frame: Change of systolic and diastolic blood pressure compared to moderate intensity exercise under normoxia (21% oxygen) at day 1, 2, 3, 4 and 5 under fasting conditions.
HOMA-IR
Time frame: Change of HOMA-IR compared to moderate intensity exercise under normoxia (21% oxygen) at day 5 under fasting conditions
Gene/protein expression of AMPK and phosphorylation of AMPK in skeletal muscle tissue
Time frame: Change of gene/protein expression of AMPK in skeletal muscle tissue compared to moderate intensity exercise under normoxia (21% oxygen) at day 5, under fasting conditions, when skeletal muscle biopsy will be collected
Systemic concentration of interleukin-8 (IL-8; inflammatory marker)
Time frame: Change of concentrations of IL-8 compared to moderate intensity exercise under normoxia (21% oxygen) during fasting conditions at day 5
Systemic concentration of tumor necrosis factor alpha (TNF-alpha; inflammatory marker)
Time frame: Change of concentrations of TNF-alpha compared to moderate intensity exercise under normoxia (21% oxygen) during fasting conditions at day 5
Systemic concentration of interferon-gamma (IFN-gamma; inflammatory marker)
Time frame: Change of concentrations of IFN-gamma compared to moderate intensity exercise under normoxia (21% O2) during fasting conditions at day 5
Systemic concentration of interleukin-6 (IL-6; inflammatory marker)
Time frame: Change of concentrations of IL-6 compared to moderate intensity exercise under normoxia (21% oxygen) during fasting conditions at day 5
Fasting and postprandial plasma glucose concentration
Time frame: Change of fasting and postprandial plasma glucose concentrations (mmol/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Fasting and postprandial plasma insulin concentration
Time frame: Change of fasting and postprandial plasma insulin concentrations (mU/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Fasting and postprandial plasma free fatty acids concentration
Time frame: Change of fasting and postprandial plasma free fatty acids concentrations (μmol/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Fasting and postprandial plasma glycerol concentration
Time frame: Change of fasting and postprandial plasma glycerol concentrations (μmol/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Fasting and postprandial plasma triglycerides concentration
Time frame: Change of fasting and postprandial plasma triglycerides concentrations (μmol/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Fasting and postprandial plasma lactate concentration
Time frame: Change of fasting and postprandial plasma lactate concentrations (mmol/L) compared to moderate intensity exercise under normoxia (21% oxygen) at day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity exercise under mild normobaric hypoxia and normoxia in people with Obesity and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average 24 hour glucose concentration (at day 4) (time frame: Change of average glucose concentration compared to moderate intensity exercise under normoxia (21% oxygen) at day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.