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

Abdominal Obesity Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01435057
• Other study ID #: STEN
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2011
• Last updated: May 27, 2015
• Start date: April 2011
• Est. completion date: April 2016

Study information

• Verified date: May 2015
• Source: University of Leipzig
• Contact: Matthias Blüher, prof., MD
• Phone: +493419715984
• Email: bluma[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity, Abdominal

Intervention

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

Locations

Country	Name	City	State
Germany	University of Leipzig, Department of Medicine	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	MRI	Changes from Baseline in abdominal visceral and subcutaneous fat area	Baseline, 12 and 24 months after randomisation	No
Secondary	BIA	Changes from Baseline in total body fat mass	Baseline, 6, 12, 18 and 24 months after randomisation	No
Secondary	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	No
Secondary	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	No
Secondary	indirect calorimetry	Changes from Baseline in resting energy expenditure	Baseline, 6, 12, 18 and 24 months after randomisation	No
Secondary	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	No
Secondary	inflammatory parameters	Changes from Baseline in inflammatory parameters	Baseline and every 3 months during intervention	No
Secondary	adipokine serum concentrations	Changes from Baseline in adipokine serum concentrations	Baseline and every 3 months during intervention	No