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

Primary Purpose

Abdominal Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
exercise training
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Obesity focused on measuring Abdominal Obesity, training, fat, insulin, glucose, diet

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Leipzig, Department of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

endurance training

strength training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

MRI
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
Changes from Baseline in abdominal visceral and subcutaneous fat area
BIA
Changes from Baseline in total body fat mass
compliance to the 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
Changes from Baseline in individual well being as measured by SF-36
indirect calorimetry
Changes from Baseline in resting energy expenditure
fasting plasma glucose
Changes from Baseline in fasting plasma glucose, insulin sensitivity and insulin secretion determined in oral glucose tolerance tests
inflammatory parameters
Changes from Baseline in inflammatory parameters
adipokine serum concentrations
Changes from Baseline in adipokine serum concentrations

Full Information

First Posted
May 11, 2011
Last Updated
May 27, 2015
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT01435057
Brief Title
Effects of Different Exercise Training Regimens on Visceral Fat Dynamic and Resting Energy Expenditure in Obese Patients
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: Abdominal visceral adipose tissue area dynamic (MRI studies) Abdominal subcutaneous adipose tissue area dynamic (MRI studies) Total body fat mass changes (bioelectrical impedance analysis) Changes in resting energy expenditure (indirect calorimetry) Changes in parameters of glucose metabolism, insulin sensitivity and lipid profile 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity
Keywords
Abdominal Obesity, training, fat, insulin, glucose, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endurance training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
strength training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
exercise training
Intervention Description
comparison of strength versus endurance training (two or three times a week, 60 minutes per training session) over 24 months
Primary Outcome Measure Information:
Title
MRI
Description
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
Time Frame
Baseline and after 12 months after randomisation
Secondary Outcome Measure Information:
Title
MRI
Description
Changes from Baseline in abdominal visceral and subcutaneous fat area
Time Frame
Baseline, 12 and 24 months after randomisation
Title
BIA
Description
Changes from Baseline in total body fat mass
Time Frame
Baseline, 6, 12, 18 and 24 months after randomisation
Title
compliance to the intervention
Description
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
Time Frame
over 24 months of intervention
Title
well being as measured by SF-36
Description
Changes from Baseline in individual well being as measured by SF-36
Time Frame
Baseline and every 6 months during intervention
Title
indirect calorimetry
Description
Changes from Baseline in resting energy expenditure
Time Frame
Baseline, 6, 12, 18 and 24 months after randomisation
Title
fasting plasma glucose
Description
Changes from Baseline in fasting plasma glucose, insulin sensitivity and insulin secretion determined in oral glucose tolerance tests
Time Frame
Baseline and every 12 months
Title
inflammatory parameters
Description
Changes from Baseline in inflammatory parameters
Time Frame
Baseline and every 3 months during intervention
Title
adipokine serum concentrations
Description
Changes from Baseline in adipokine serum concentrations
Time Frame
Baseline and every 3 months during intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Blüher, prof., MD
Phone
+493419715984
Email
bluma@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Bauernfeind
Phone
+493419716266
Email
nicole.bauernfeind@zks.uni-leipzig.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Blüher, prof., MD
Organizational Affiliation
University of Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig, Department of Medicine
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Blüher, prof., MD
Phone
+493419715984
Email
bluma@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Nicole Bauernfeind
Phone
+493419716266
Email
nicole.bauernfeind@zks.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Matthias Blüher, prof., MD

12. IPD Sharing Statement

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

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