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

NCT ID: NCT01435057

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2016-04-30

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:

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.

Conditions

Abdominal Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

exercise training

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

exercise training

Intervention Type: PROCEDURE

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

Interventions

exercise training

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Matthias Bluher

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias Blüher, prof., MD

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Locations

University of Leipzig, Department of Medicine

Leipzig, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Matthias Blüher, prof., MD

Role: CONTACT

bluma@medizin.uni-leipzig.de

+493419715984

Nicole Bauernfeind

Role: CONTACT

nicole.bauernfeind@zks.uni-leipzig.de

+493419716266

Facility Contacts

Matthias Blüher, prof., MD

Role: primary

bluma@medizin.uni-leipzig.de

+493419715984

Nicole Bauernfeind

Role: backup

nicole.bauernfeind@zks.uni-leipzig.de

+493419716266

Other Identifiers

STEN

Identifier Type: -

Identifier Source: org_study_id