Clinical trial NCT01435057: Effects of Different Exercise Training Regimens on Visceral Fat Dynamic and Resting Energy Expenditure in Obese Patients
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Obesity
Keywords: Abdominal Obesity
training
fat
insulin
glucose
diet
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2011-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MRI
timeFrame: Baseline and after 12 months after randomisation
Secondary outcomes:
measure: MRI
timeFrame: Baseline, 12 and 24 months after randomisation
measure: BIA
timeFrame: Baseline, 6, 12, 18 and 24 months after randomisation
measure: compliance to the intervention
timeFrame: over 24 months of intervention
measure: well being as measured by SF-36
timeFrame: Baseline and every 6 months during intervention
measure: indirect calorimetry
timeFrame: Baseline, 6, 12, 18 and 24 months after randomisation
measure: fasting plasma glucose
timeFrame: Baseline and every 12 months
measure: inflammatory parameters
timeFrame: Baseline and every 3 months during intervention
measure: adipokine serum concentrations
timeFrame: Baseline and every 3 months during intervention
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig, Department of Medicine
state: Saxony
Study officials:
affiliation: University of Leipzig
name: Matthias Blüher, prof., MD
role: PRINCIPAL_INVESTIGATOR
References: