NCT03203317

Brief Summary

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

Trial Health

87
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

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

April 26, 2017

Last Update Submit

July 29, 2017

Conditions

ExerciseInsulin Sensitivity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Insulin-stimulation

EXPERIMENTAL

2 h insulin-clamp

Drug: Insulin

Exercise

EXPERIMENTAL

10 min of maximal exercise

Other: Exercise

Interventions

InsulinDRUG

2 h insulin clamp

Insulin-stimulation
ExerciseOTHER

Cycling exercise

Exercise

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • smoker
  • allergy towards insulin
  • chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

August Krogh Building

Copenahgen, Denmark

Location

MeSH Terms

Conditions

Motor ActivityInsulin Resistance

Interventions

InsulinExercise

Condition Hierarchy (Ancestors)

BehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsMotor 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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 26, 2017

First Posted

June 29, 2017

Study Start

May 1, 2017

Primary Completion

July 26, 2017

Study Completion

July 26, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

DK(1)