The Effect of Blood Volume Changes on the Glucose Tolerance (BV-GT)

November 19, 2015 updated by: Carsten Lundby

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

Unknown

Conditions

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Zurich, Switzerland, 8057
        • Recruiting
        • Institute of Physiology, University of Zurich
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Carsten Lundby, Prof. Dr., Institute of Physiology, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

November 13, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Estimate)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

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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