NCT02001805

Brief Summary

The investigators wish to compare very active runners in healthy untrained control subjects on a number of parameters. The project aims to understand the underlying mechanisms by which physical inactivity causes diseases. This the investigators will study the full spectrum of physical activity, from the most inert of the most active people. The investigators have already collected muscle biopsies and established stem cells from people with Type 2 diabetes, obese healthy and normal weight healthy. In this study, the investigators will establish a cohort of highly physically active marathon runners. In a case-control design, the investigators compare muscle stem cell function across the entire spectrum of physical activity / inactivity.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Typical duration for all trials

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

December 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
Last Updated

December 5, 2013

Status Verified

November 1, 2013

Enrollment Period

3 years

First QC Date

May 18, 2011

Last Update Submit

November 28, 2013

Conditions

Outcome Measures

Primary Outcomes (5)

  • Fitness

    Lactate threshold VO2max Running economy Lactate Peak

    one day

  • Cognitive Function

    Memory, concentration, personality, intelligence

    one day

  • Blood

    3 hour Oral Glucose Tolerance test (glucose, insulin, c-peptide) Fasting blood measurements ( lever, kidney, immune system, colesterol parameters) DNA

    one day

  • Muscle biopsy

    Gene transcription Methylation

    one day

  • Body Composition

    DXA scanning: Fat%, muscle mass, lean body mass, BMD MR scanning: Amount of visceral fat, volume of thighs

    one day

Secondary Outcomes (1)

  • Activity level and diet

    7 days

Study Arms (2)

Marathon runners

Very active runners that have been running \> 10 marathons, 2 within the last year, or an amount of 50 km/week for the last 5 years

Control subjects

Healthy normal weight control subjects, with a low activity level \< 1 hour phsyical activity pr. week. They are matched with runners on age, BMI and gender

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Runners with high amount of training

You may qualify if:

  • marathons, 2 within the last year or 50 km/week the last 5 years

You may not qualify if:

  • smokers, any medication, chronic diseases, digestion of performance enhancing drugs, pregnancy, alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Inflammation and Metabolism, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, muscle tissue

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bente K Pedersen, Doctor

    Center of Inflammation and Metabolism

    STUDY DIRECTOR

Central Study Contacts

Louise S Hansen, Cand. Scient

CONTACT

Matthew Laye, Post doc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Section CIM

Study Record Dates

First Submitted

May 18, 2011

First Posted

December 5, 2013

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 5, 2013

Record last verified: 2013-11

Locations