Myocellular Signalling in Skeletal Muscle | NCT03203317

Studies
Myocellular Signalling in Skeletal Muscle

NCT03203317

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Aug 1, 2017Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Exercise
Insulin Sensitivity

Interventions

Insulin
Exercise

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

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

May 1, 2017Actual

Primary Completion Date

Jul 26, 2017Actual

Completion Date

Jul 26, 2017Actual

First Submitted Date

Apr 26, 2017

First Submission Date that Met QC Criteria

Jun 27, 2017

First Posted Date

Jun 29, 2017Actual

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

Jul 29, 2017

Last Update Posted Date

Aug 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will investigate myocellular signalling in skeletal muscle after insulin-stimulation and exercise in healthy young men

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
Insulin-stimulation	Experimental	2 h insulin-clamp	Drug: Insulin
Exercise	Experimental	10 min of maximal exercise	Other: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin	Drug	2 h insulin clamp	Insulin-stimulation
Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in muscle phospho-proteome signature	proteomic analysis of mixed muscle homogenate	Before and after 10 minutes of exercise, as well as before and after a 2 hour insulin stimulation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy
informed consent
habitual training (2-5 h/week)
VO2max of 40-60 ml/min/kg
lean mass 55-65 kg

Exclusion Criteria:

smoker
allergy towards insulin
chronic disease

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
August Krogh Building		Copenahgen			Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D001519	Behavior
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007328	Insulin
D015444	Exercise

Ancestor Terms

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided