- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02612597
The Effect of Blood Volume Changes on the Glucose Tolerance (BV-GT)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carsten Lundby, Prof. Dr.
- Phone Number: +41 +41 44 635 50 52
- Email: carsten.lundby@access.uzh.ch
Study Locations
-
-
-
Zurich, Switzerland, 8057
- Recruiting
- Institute of Physiology, University of Zurich
-
Contact:
- Carsten Lundby, Prof. Dr.
- Phone Number: +41 +41 44 635 50 52
- Email: carsten.lundby@access.uzh.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Bedrest:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Known allergies against Fragmin or Heparin
Training:
Inclusion criteria:
- Informed consent as documented by signature
- Age: 35-50
- BMI: 30-40
- Fat%: 30-40 %
- maximal oxygen uptake: 20-35 ml O2/min/kg
- HbA1c: 5.5 - 7.0 %
Exclusion criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bedrest
4 days of bedrest
|
|
Experimental: Exercise Training
6 weeks of aerobic endurance exercise training with 4 supervised sessions per week at an average intensity of 65 % of maximal heart rate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in blood volume
Time Frame: Baseline and 4 days
|
Baseline and 4 days
|
Change in glucose tolerance
Time Frame: Baseline and 4 days
|
Baseline and 4 days
|
Change in blood volume
Time Frame: Baseline and 6 weeks
|
Baseline and 6 weeks
|
Change in glucose tolerance
Time Frame: Baseline and 6 weeks
|
Baseline and 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carsten Lundby, Prof. Dr., Institute of Physiology, University of Zurich
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-Nr. 2015-0453
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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