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

Study Overview
=================
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.

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)

Conditions
-----------------
Abdominal Obesity

Intervention / Treatment
-----------------
* Procedure: exercise training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: endurance training<br>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<br>* comparison of strength versus endurance training (two or three times a week, 60 minutes per training session) over 24 months<br>|
| Active Comparator: strength training<br>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<br>* comparison of strength versus endurance training (two or three times a week, 60 minutes per training session) over 24 months<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal Obesity, training, fat, insulin, glucose, diet