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Effects of Different Exercise Training Regimens on Visceral Fat Dynamic and Resting Energy Expenditure in Obese Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Matthias Bluher, University of Leipzig.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01435057
First Posted: September 15, 2011
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matthias Bluher, University of Leipzig
  Purpose
In this project, the investigators will test the hypothesis that predominant (two to three times a week 60 min) strength training is more effective in reducing visceral fat mass than endurance training in obese patients.

Condition Intervention
Abdominal Obesity Procedure: exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monocentric, Randomized, Controlled Study for Reduction on Visceral Fat Dynamic and Resting Energy Expenditure in Obese Patients Via Strength Versus Endurance Training (STEN Study - STrength Versus ENdurance Training)

Further study details as provided by Matthias Bluher, University of Leipzig:

Primary Outcome Measures:
  • MRI [ Time Frame: Baseline and after 12 months after randomisation ]
    Change from Baseline in abdominal visceral fat area as determined by MRI scans at the level of L4-L5 after 12 months of training intervention


Secondary Outcome Measures:
  • MRI [ Time Frame: Baseline, 12 and 24 months after randomisation ]
    Changes from Baseline in abdominal visceral and subcutaneous fat area

  • BIA [ Time Frame: Baseline, 6, 12, 18 and 24 months after randomisation ]
    Changes from Baseline in total body fat mass

  • compliance to the intervention [ Time Frame: over 24 months of intervention ]
    compliance to the intervention of training (strength or endurance) as measured by the number of realized training units. Non-compliance = cumulative time bigger than six weeks per year

  • well being as measured by SF-36 [ Time Frame: Baseline and every 6 months during intervention ]
    Changes from Baseline in individual well being as measured by SF-36

  • indirect calorimetry [ Time Frame: Baseline, 6, 12, 18 and 24 months after randomisation ]
    Changes from Baseline in resting energy expenditure

  • fasting plasma glucose [ Time Frame: Baseline and every 12 months ]
    Changes from Baseline in fasting plasma glucose, insulin sensitivity and insulin secretion determined in oral glucose tolerance tests

  • inflammatory parameters [ Time Frame: Baseline and every 3 months during intervention ]
    Changes from Baseline in inflammatory parameters

  • adipokine serum concentrations [ Time Frame: Baseline and every 3 months during intervention ]
    Changes from Baseline in adipokine serum concentrations


Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: endurance training

Endurance training:

Supervised, twice a week, each training session consists of a 20 min warm up and cool down period and a minimum of 40min tread mill, rawing device or bicycle training.

During the study period of 24 months, we will perform an open randomized, prospective training intervention study comparing the effects of three times a week either strength or endurance training on reduction of visceral fat area as determined by MRI scans at the level of L4-L5.

Procedure: exercise training
comparison of strength versus endurance training (two or three times a week, 60 minutes per training session) over 24 months
Active Comparator: strength training

Strength training:

Supervised, twice a week, each training session consists of a 20 min warm up and cool down period and a minimum of 40min circle training

During the study period of 24 months, we will perform an open randomized, prospective training intervention study comparing the effects of two to three times a week either strength or endurance training on reduction of visceral fat area as determined by MRI scans at the level of L4-L5.

Procedure: exercise training
comparison of strength versus endurance training (two or three times a week, 60 minutes per training session) over 24 months

Detailed Description:

Strength training (ST) was shown to be more effective than endurance training (ET) in improving glycemic control in the treatment of type 2 diabetes. However, it is unknown, whether different training strategies have different effects on the preferential visceral adipose tissue reduction and changes in resting energy expenditure in a population with abdominal obesity. We will therefore compare ST and ET (two to three times a week, 60 minutes per training session) in addition to a restricted energy intake of 1500kcal per day for women and 1800kcal per day for men in a prospective study of 200 individuals with abdominal obesity defined by a waist circumference > 102 cm for males and > 88 cm for females and a BMI > 35 kg/m² with regard to:

  1. Abdominal visceral adipose tissue area dynamic (MRI studies)
  2. Abdominal subcutaneous adipose tissue area dynamic (MRI studies)
  3. Total body fat mass changes (bioelectrical impedance analysis)
  4. Changes in resting energy expenditure (indirect calorimetry)
  5. Changes in parameters of glucose metabolism, insulin sensitivity and lipid profile
  6. Changes in circulating adipokines and markers of inflammation In addition, we will search for novel serum parameters, which predict the individual training response by a serum metabolomics/ proteomics approach.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI >= 35 kg/m2
  • waist circumference >102cm (men), >88cm (women)
  • age 18 - 60 years
  • written informed consent

Exclusion Criteria:

  • type 1 or type 2 diabetes
  • fasting plasma glucose >= 6.0 mmol/l
  • 2h-OGTT (oral glucose tolerance test) glucose >= 11.1 mmol/l
  • any chronic inflammatory or malignant disease
  • medical treatment which influences glucose metabolism
  • drug or alcohol abuse
  • psychiatric disorders
  • untreated thyroid dysfunction
  • cardiac pacemaker or other contraindication for MRI
  • attendant therapy with oral antidiabetic medication, GLP-1 mimetics or analoga, Insulin, anti-obesity medication (orlistat, sibutramine), Falithrom, antipsychotic drugs, any chemotherapeutics
  • pregnant or nursing women
  • expected low compliance
  • current participation in another investigational trial
  • last exercise training <= 6 months ago
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435057


Contacts
Contact: Matthias Blüher, prof., MD +493419715984 bluma@medizin.uni-leipzig.de
Contact: Nicole Bauernfeind +493419716266 nicole.bauernfeind@zks.uni-leipzig.de

Locations
Germany
University of Leipzig, Department of Medicine Recruiting
Leipzig, Saxony, Germany, 04103
Contact: Matthias Blüher, prof., MD    +493419715984    bluma@medizin.uni-leipzig.de   
Contact: Nicole Bauernfeind    +493419716266    nicole.bauernfeind@zks.uni-leipzig.de   
Principal Investigator: Matthias Blüher, prof., MD         
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Matthias Blüher, prof., MD University of Leipzig
  More Information

Responsible Party: Matthias Bluher, medical doctor, University of Leipzig
ClinicalTrials.gov Identifier: NCT01435057     History of Changes
Other Study ID Numbers: STEN
First Submitted: May 11, 2011
First Posted: September 15, 2011
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Matthias Bluher, University of Leipzig:
Abdominal Obesity
training
fat
insulin
glucose
diet

Additional relevant MeSH terms:
Obesity, Abdominal
Obesity
Overnutrition
Nutrition Disorders