NCT01636349

Brief Summary

The present study investigates the effects of recreational soccer in type 2 diabetic men in regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in 6 month structured recreational soccer training and 10 men act as control with no change in lifestyle. Testing consisting of fasting blood samples, muscle biopsies, Dexa-scans, echocardiography, maximal oxygen consumption, Yo-Yo interval test, bloodpressure, Resting heart rate, and endothelial function (Itamar, Endopat)will be performed at baseline, after 12 and 24 weeks, respectively. The study examines the hypothesis that the high-intensity aerobic work profile combined with a high anaerobic turnover from the nature of soccer (accelerations, decelerations, turns, sudden stops) will improve glycaemic control, muscle and cardiac function and taken together will improve the overall health profile in type 2 diabetic men

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2011

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

Study Start

First participant enrolled

November 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

1.1 years

First QC Date

July 5, 2012

Last Update Submit

December 6, 2012

Conditions

Type 2 DiabetesHypertensionObesityMetabolic Syndrome

Keywords

Type 2 diabeteshypertensionobesitymetabolic syndrome

Outcome Measures

Primary Outcomes (2)

  • Cardiac adaptations

    All participants are examined with 2d- echocardiography, speckletracking, strain and colordoppler

    Analysis of data at baseline, 12 and 24 weeks

  • muscular adaptations

    muscle biopsies are obtaned from the vastus lateralis muscle at baseline, after 12 and 24 weeks, respectively

    Data analysis after baseline, 12 and 24 weeks

Secondary Outcomes (2)

  • Vascular function

    Data analysis after baseline, 12 and 24 weeks

  • glycaemic control

    Data analysis after baseline, 12 and 24 weeks

Study Arms (2)

Recreational soccer training

EXPERIMENTAL

12 men participate in recreational soccer training for 6 months

Other: soccer exercise or continued daily lifestyle

Control group

NO INTERVENTION

10 subjects serve as a control group with no change in lifestyle in the study period

Interventions

soccer exercise or continued daily lifestyleOTHER

Recreational soccer or continued unchanged lifestyle

Also known as: Soccer training
Recreational soccer training

Eligibility Criteria

Age35 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 2 diabetes diagnosed
  • years old men

You may not qualify if:

  • Smoker
  • Ischaemic heart Disease
  • Congestive heart failure
  • Joint or limp pains to an extent where recreational soccer can not be performed.
  • Apoplexia.
  • Anticoagulant therapy (aspirin accepted)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, Copenhagen, 2200, Denmark

Location

Related Publications (1)

  • Andersen TR, Schmidt JF, Thomassen M, Hornstrup T, Frandsen U, Randers MB, Hansen PR, Krustrup P, Bangsbo J. A preliminary study: effects of football training on glucose control, body composition, and performance in men with type 2 diabetes. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:43-56. doi: 10.1111/sms.12259. Epub 2014 Jun 5.

    PMID: 24903461DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinism

Study Officials

  • jakob friis schmidt, MD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD student

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 10, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 7, 2012

Record last verified: 2012-12

Locations

DK(1)