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

NCT01435057 | Unknown

• 1 other identifier: STEN
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Obesity

Keywords

Abdominal Obesity; training; fat; insulin; glucose; diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• MRI

  Baseline, 12 and 24 months after randomisation

• BIA

  Baseline, 6, 12, 18 and 24 months after randomisation

• compliance to the intervention

  over 24 months of intervention

• well being as measured by SF-36

  Baseline and every 6 months during intervention

• indirect calorimetry

  Baseline, 6, 12, 18 and 24 months after randomisation

Study Arms (2)

endurance training

ACTIVE COMPARATOR

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

strength training

ACTIVE COMPARATOR

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

Interventions

exercise training PROCEDURE

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

endurance training; strength training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• type 1 or type 2 diabetes
• fasting plasma glucose \>= 6.0 mmol/l
• h-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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University of Leipzig, Department of Medicine

Leipzig, Saxony, 04103, Germany

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal; Platelet Glycoprotein IV Deficiency; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Matthias Blüher, prof., MD

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Blüher, prof., MD

CONTACT

+493419715984; bluma@medizin.uni-leipzig.de

Nicole Bauernfeind

CONTACT

+493419716266; nicole.bauernfeind@zks.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: September 15, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

DE (1)