NCT00817440

Brief Summary

Hypothesis: under fasting there will primarily be an activation of growth hormone(GH) signalpathways and a inhibition of insulin signalpathways, and the opposite will happen under physical activity. Primarily we will investigate markers for GH and insulin signaltransduction in muscle- and fat-biopsies after fasting for 72 hours and after 1 hour of ergometer-cycling at 65% Vo2max. In addition to this we will investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

Enrollment Period

5 months

First QC Date

January 5, 2009

Last Update Submit

January 10, 2011

Conditions

Healthy

Keywords

growth hormone insulin signaltransduction signalpathwaysgrowth hormone and insulin signalpathways

Outcome Measures

Primary Outcomes (1)

  • Growth hormone and insulin signal pathways

    30 min

Secondary Outcomes (1)

  • aminoacid and glucose turnover

    4 hours

Study Arms (3)

Control

NO INTERVENTION

control: muscle and fat biopsies and basal aminoacid and glucose turnover

Exercise

EXPERIMENTAL

1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1.

Other: Exercise

Fasting

EXPERIMENTAL

3 days of fasting and then the same as arm 1

Other: Fasting

Interventions

ExerciseOTHER

1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1.

Exercise
FastingOTHER

3 days of fasting and then the same as arm 1

Fasting

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men
  • Body mass index (BMI) 20-26
  • age 18-45 years

You may not qualify if:

  • any kind of disease
  • any use of medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus sygehus

Aarhus, Jylland, 8000, Denmark

Location

MeSH Terms

Interventions

ExerciseAngptl4 protein, mouse

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

December 1, 2008

Primary Completion

May 1, 2009

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

DK(1)