NCT02268292

Brief Summary

The subjects with MetS or type 2 diabetes were enrolled for this exercise-training program. All participators underwent an indoor bicycle exercise for twelve weeks. In addition to demographic data and biochemical tests were determined after an overnight fasting. Extension of muscle strength was detected in the dominant lower extremity.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

2 years

First QC Date

September 27, 2014

Last Update Submit

October 15, 2014

Conditions

Metabolic Cardiovascular Syndrome

Keywords

Metabolic syndromeDiabetesMuscle strengthAerobic exerciseBicycleBrain-derived neurotrophic factor

Outcome Measures

Primary Outcomes (1)

  • Metabolic syndrome

    Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria

    12 weeks

Secondary Outcomes (3)

  • Muscle strength

    12 weeks

  • Brain-derived neurotrophic factor

    12 weeks

  • Arterial stiffness

    12 weeks

Study Arms (1)

Bicycle Exercise

EXPERIMENTAL

Bicycle Exercise for 12 weeks

Behavioral: bicycle exercise

Interventions

bicycle exerciseBEHAVIORAL

All enrolled subjects received a scheduled twelve-week exercise program. A commercially available bicycle (Giant CS800, Taichung, Taiwan) with an indoor bicycle stand (Giant Cyclotron Mag, Taichung, Taiwan) was used as the home exercise training modality.

Bicycle Exercise

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult with metabolic syndrome or type 2 diabetes

You may not qualify if:

  • hyperglycemic crisis or HbA1c \> 12%;
  • serum creatinine levels greater than 200 mmol/L;
  • acute or chronic infectious diseases;
  • limitations in the ability to undertake regular exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tsai SW, Chan YC, Liang F, Hsu CY, Lee IT. Brain-derived neurotrophic factor correlated with muscle strength in subjects undergoing stationary bicycle exercise training. J Diabetes Complications. 2015 Apr;29(3):367-71. doi: 10.1016/j.jdiacomp.2015.01.014. Epub 2015 Feb 7.

    PMID: 25682570DERIVED

MeSH Terms

Conditions

Metabolic SyndromeDiabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Taichung Veterans General Hospital

Study Record Dates

First Submitted

September 27, 2014

First Posted

October 20, 2014

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

October 20, 2014

Record last verified: 2014-10