Effects of Fasting and Exercise on Insulin and GH Signalt... | NCT00817440

Studies
Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat

NCT00817440

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jan 11, 2011Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Exercise
Fasting

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

May 2009Actual

Completion Date

Not provided

First Submitted Date

Jan 5, 2009

First Submission Date that Met QC Criteria

Jan 5, 2009

First Posted Date

Jan 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2011

Last Update Posted Date

Jan 11, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Other	1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1.	Exercise

Measure	Description	Time Frame
Growth hormone and insulin signal pathways		30 min

Measure	Description	Time Frame
aminoacid and glucose turnover		4 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

any kind of disease
any use of medicine

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus sygehus		Aarhus	Jylland	8000	Denmark

Type	Date	Date Unknown
Release	Nov 3, 2011
Reset	Dec 6, 2011
Release	Jan 20, 2012
Reset	Feb 21, 2012
Release	Jun 18, 2012
Reset	Jul 19, 2012
Release	Aug 3, 2012
Reset	Aug 31, 2012

Submission Tracking

Estimated Results First Submitted Date

Nov 3, 2011

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 3, 2011			Dec 6, 2011
Jan 20, 2012

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
C407088	Angptl4 protein, mouse

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided