NCT02612597

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

1.2 years

First QC Date

November 13, 2015

Last Update Submit

November 19, 2015

Conditions

Keywords

before and after bedresthealthy untrainedbefore and after exercise training

Outcome Measures

Primary Outcomes (4)

  • Change in blood volume

    Baseline and 4 days

  • Change in glucose tolerance

    Baseline and 4 days

  • Change in blood volume

    Baseline and 6 weeks

  • Change in glucose tolerance

    Baseline and 6 weeks

Study Arms (2)

Bedrest

EXPERIMENTAL

4 days of bedrest

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

Other: Exercise Training

Interventions

BedrestOTHER
Bedrest
Exercise Training

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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 %
  • Chronic diseases
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Physiology, University of Zurich

Zurich, Canton of Zurich, 8057, Switzerland

RECRUITING

MeSH Terms

Conditions

Overweight

Interventions

Bed RestExercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Carsten Lundby, Prof. Dr.

    Institute of Physiology, University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carsten Lundby, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 24, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations