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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Obesity
• Intervention / Treatment: Procedure: exercise training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthias Blüher, prof., MD; Phone Number: +493419715984; Email: bluma@medizin.uni-leipzig.de
• Study Contact Backup: Name: Nicole Bauernfeind; Phone Number: +493419716266; Email: nicole.bauernfeind@zks.uni-leipzig.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Recruiting
      • University of Leipzig, Department of Medicine
      • Contact: Matthias Blüher, prof., MD; Phone Number: +493419715984; Email: bluma@medizin.uni-leipzig.de
      • Contact: Nicole Bauernfeind; Phone Number: +493419716266; Email: nicole.bauernfeind@zks.uni-leipzig.de
      • Principal Investigator: Matthias Blüher, prof., MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and after 12 months after randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI	Changes from Baseline in abdominal visceral and subcutaneous fat area	Baseline, 12 and 24 months after randomisation
BIA	Changes from Baseline in total body fat mass	Baseline, 6, 12, 18 and 24 months after randomisation
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	over 24 months of intervention
well being as measured by SF-36	Changes from Baseline in individual well being as measured by SF-36	Baseline and every 6 months during intervention
indirect calorimetry	Changes from Baseline in resting energy expenditure	Baseline, 6, 12, 18 and 24 months after randomisation
fasting plasma glucose	Changes from Baseline in fasting plasma glucose, insulin sensitivity and insulin secretion determined in oral glucose tolerance tests	Baseline and every 12 months
inflammatory parameters	Changes from Baseline in inflammatory parameters	Baseline and every 3 months during intervention
adipokine serum concentrations	Changes from Baseline in adipokine serum concentrations	Baseline and every 3 months during intervention

Collaborators and Investigators

• Sponsor: University of Leipzig
• Investigators: Principal Investigator: Matthias Blüher, prof., MD, University of Leipzig

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: May 11, 2011
• First Submitted That Met QC Criteria: September 14, 2011
• First Posted (Estimate): September 15, 2011

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: insulin; training; diet; glucose; fat; Abdominal Obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Obesity, Abdominal
• Other Study ID Numbers: STEN