HealthyBV-GTNCT02612597
The Effect of Blood Volume Changes on the Glucose Tolerance
A study testing Bedrest and Exercise Training in people with Healthy and Overweight, run by Carsten Lundby at 1 site in Switzerland.
Trial summary
In this study the investigators would like to elaborate on the mechanisms that lead to a higher insulin sensitivity after exercise training and a lower insulin sensitivity after bedrest. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight
- What is being tested?
- Bedrest and Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2015to Apr 2016
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent as documented by signature
- Age: 18-35
- healthy (no chronic diseases)
- BMI: 19-25
- maximal oxygen uptake: 35-50 ml O2/min/kg
- Informed consent as documented by signature
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- Age: 35-50
- BMI: 30-40
- Fat%: 30-40 %
- maximal oxygen uptake: 20-35 ml O2/min/kg
- HbA1c: 5.5 - 7.0 %
Who cannot join
- chronic diseases
- any health problems that do not allow the subjects to participate in the measurements (i.e. heart defect)
- History of familiar history (1st grade relatives) of venous thrombic-embolism or renal insufficiency
- Blood donation in the last month
- Any medication with known influence on blood volume, glucose metabolism and body weight
- Stay above 2500 m for more than 1 day
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- Known allergies against Fragmin or Heparin
- Training:
- Chronic diseases
- Any health problems that do not allow the subjects to participate in the measurements (i.e. heart defect)
- Blood donation in the last month
- Any medication with known influence on blood volume, glucose metabolism and body weight
- Stay above 2500 m for more than 1 day
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Institute of Physiology, University of Zurich
Zurich, Canton of Zurich, 8057
Carsten Lundby, Prof. Dr., +41 44 635 50 52 ext. +41, carsten.lundby@access.uzh.ch
About this study
Official title: The Effect of Blood Volume Changes After Bed Rest and Aerobic Exercise Training on the Glucose Tolerance
In this study the investigators would like to elaborate on the mechanisms that lead to a higher insulin sensitivity after exercise training and a lower insulin sensitivity after bedrest.
The investigators speculate that the concomitant chances in blood volume during training and bedrest might explain the changed insulin sensitivity because with a changing blood volume also the dilution space of the glucose will change.
Read more
Furthermore, the investigators would like to work on the influence of a changed capacity of skeletal muscle for glucose uptake and glycogen storage on the glucose sensitivity.
Therefore, A) a bed rest study with healthy untrained subjects and B) a training study with obese pre-diabetic patients will be conducted.
Read the detailed description
While there is little doubt that physical inactivity leads to reduced insulin sensitivity and in contrast hereto that physical activity improves insulin sensitivity the underlying mechanisms are still to a large extend unknown. With this study the investigators wish to test two independent hypotheses that may explain the observed changes:
The first hypothesis is that part of the explanation for the known increase in circulating levels of glucose in response to an oral glucose tolerance test (indicating reduced insulin sensitivity) following bed rest is due to a concomitantly reduced blood volume and thereby dilution space.
In addition the investigators also speculate that the reduced glucose response to an oral glucose tolerance test (indicating improved insulin sensitivity) after a training period is related to the exercise induced increase in blood volume, and hence an increased dilution space.
Based on this, the hypothesis to be tested with these two experimental approaches (bed rest and aerobic exercise training), is that at least part of the changes observed in the glucose tolerance following bed rest and aerobic exercise training are related to concomitantly occurring changes in blood volume.
The second hypothesis to be tested is that another important contributor to the changes in circulating glucose levels following an oral glucose tolerance test after bed rest and physical training are related to diminished or improved capacity for skeletal muscle glucose uptake and glycogen storage, respectively. The rationale here fore are that exercise training increases skeletal muscle glycogen content and storage capacity in healthy and type 2 diabetic patients, respectively, and that bed rest does the opposite.
To test this hypothesis two different intervention studies will be conducted. Study 1 is a bed rest study with healthy untrained subjects and study 2 is a training study with obese "pre-diabetic patients".
- Conditions
- Healthy, Overweight
- Being tested
- Bedrest, Exercise Training
- Keywords
- before and after bedrest, healthy untrained, before and after exercise training
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BedrestOther
Exercise TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Bedrest | Experimental | 4 days of bedrest Receives: Other: Bedrest |
| Exercise Training | Experimental | 6 weeks of aerobic endurance exercise training with 4 supervised sessions per week at an average intensity of 65 % of maximal heart rate Receives: Other: Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood volume
Measured: Baseline and 4 days
Change in glucose tolerance
Measured: Baseline and 4 days
Change in blood volume
Measured: Baseline and 6 weeks
Change in glucose tolerance
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carsten Lundby
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carsten Lundby, Zurich Center for Integrative Human Physiology
- Investigators
- Carsten Lundby, Prof. Dr., Principal investigator, Institute of Physiology, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612597
- Sponsor's protocol ID
- KEK-ZH-Nr. 2015-0453
- Acronym
- BV-GT
- Status last verified
- Nov 2015
- First submitted
- 13 Nov 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Volume Changes After Bed Rest and Aerobic Exercise Training on the Glucose Tolerance
- ClinicalTrials.gov ID
- NCT02612597
- Acronym / sponsor ID
- BV-GT / KEK-ZH-Nr. 2015-0453
- Conditions
- Healthy, Overweight
- Keywords
- before and after bedrest, healthy untrained, before and after exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Carsten LundbyUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 24 Nov 2015 (estimated)
- 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.
In this study the investigators would like to elaborate on the mechanisms that lead to a higher insulin sensitivity after exercise training and a lower insulin sensitivity after bedrest.
The investigators speculate that the concomitant chances in blood volume during training and bedrest might explain the changed insulin sensitivity because with a changing blood volume also the dilution space of the glucose will change.
Furthermore, the investigators would like to work on the influence of a changed capacity of skeletal muscle for glucose uptake and glycogen storage on the glucose sensitivity.
Therefore, A) a bed rest study with healthy untrained subjects and B) a training study with obese pre-diabetic patients will be conducted.
Detailed description
While there is little doubt that physical inactivity leads to reduced insulin sensitivity and in contrast hereto that physical activity improves insulin sensitivity the underlying mechanisms are still to a large extend unknown. With this study the investigators wish to test two independent hypotheses that may explain the observed changes:
The first hypothesis is that part of the explanation for the known increase in circulating levels of glucose in response to an oral glucose tolerance test (indicating reduced insulin sensitivity) following bed rest is due to a concomitantly reduced blood volume and thereby dilution space.
In addition the investigators also speculate that the reduced glucose response to an oral glucose tolerance test (indicating improved insulin sensitivity) after a training period is related to the exercise induced increase in blood volume, and hence an increased dilution space.
Based on this, the hypothesis to be tested with these two experimental approaches (bed rest and aerobic exercise training), is that at least part of the changes observed in the glucose tolerance following bed rest and aerobic exercise training are related to concomitantly occurring changes in blood volume.
The second hypothesis to be tested is that another important contributor to the changes in circulating glucose levels following an oral glucose tolerance test after bed rest and physical training are related to diminished or improved capacity for skeletal muscle glucose uptake and glycogen storage, respectively. The rationale here fore are that exercise training increases skeletal muscle glycogen content and storage capacity in healthy and type 2 diabetic patients, respectively, and that bed rest does the opposite.
To test this hypothesis two different intervention studies will be conducted. Study 1 is a bed rest study with healthy untrained subjects and study 2 is a training study with obese "pre-diabetic patients".
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bedrest | Experimental | Other: Bedrest4 days of bedrest |
| Exercise Training | Experimental | Other: Exercise Training6 weeks of aerobic endurance exercise training with 4 supervised sessions per week at an average intensity of 65 % of maximal heart rate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Informed consent as documented by signature
- Age: 18-35
- healthy (no chronic diseases)
- BMI: 19-25
- maximal oxygen uptake: 35-50 ml O2/min/kg
Key exclusion criteria (13 listed)
- chronic diseases
- any health problems that do not allow the subjects to participate in the measurements (i.e. heart defect)
- History of familiar history (1st grade relatives) of venous thrombic-embolism or renal insufficiency
- Blood donation in the last month
- Any medication with known influence on blood volume, glucose metabolism and body weight
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 |
|---|---|---|
| Bedrest | Other | Bedrest |
| Exercise Training | Other | Exercise Training |
Primary outcome
Change in blood volume
Time frame: Baseline and 4 days
Change in glucose tolerance
Time frame: Baseline and 4 days
Change in blood volume
Time frame: Baseline and 6 weeks
Change in glucose tolerance
Time frame: Baseline and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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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.
Carsten Lundby, Prof. Dr. principal investigator
Institute of Physiology, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedrest and Exercise Training in people with Healthy and Overweight, run by Carsten Lundby at 1 site in Switzerland.
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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 Nov 2015. 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 Switzerland. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carsten Lundby, Prof. Dr. (+41 44 635 50 52 ext. +41, carsten.lundby@access.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood volume (time frame: Baseline and 4 days). The study lists 4 primary outcomes in all. 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 24 Nov 2015.