Abdominal ObesityNCT01435057
Effects of Different Exercise Training Regimens on Visceral Fat Dynamic and Resting Energy Expenditure in Obese Patients
A study testing exercise training in people with Abdominal Obesity, run by University of Leipzig at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- exercise training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI >= 35 kg/m2
- waist circumference >102cm (men), >88cm (women)
- age 18 - 60 years
- written informed consent
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Leipzig, Department of Medicine
Leipzig, Saxony, 04103
Matthias Blüher, prof., MD, +493419715984, bluma@medizin.uni-leipzig.de
Nicole Bauernfeind, +493419716266, nicole.bauernfeind@zks.uni-leipzig.de
About this study
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)
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.
Read the 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.
- Conditions
- Abdominal Obesity
- Being tested
- exercise training
- Keywords
- Abdominal Obesity, training, fat, insulin, glucose, diet
- Medical subject headings
- Obesity, Abdominal, Platelet Glycoprotein IV Deficiency, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingProcedure or surgery
comparison of strength versus endurance training (two or three times a week, 60 minutes per training session) over 24 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and after 12 months after randomisation
Secondary outcomes (8)
MRI
Changes from Baseline in abdominal visceral and subcutaneous fat area
Measured: Baseline, 12 and 24 months after randomisation
BIA
Changes from Baseline in total body fat mass
Measured: 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
Measured: over 24 months of intervention
well being as measured by SF-36
Changes from Baseline in individual well being as measured by SF-36
Measured: Baseline and every 6 months during intervention
indirect calorimetry
Changes from Baseline in resting energy expenditure
Measured: 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
Measured: Baseline and every 12 months
inflammatory parameters
Changes from Baseline in inflammatory parameters
Measured: Baseline and every 3 months during intervention
adipokine serum concentrations
Changes from Baseline in adipokine serum concentrations
Measured: Baseline and every 3 months during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Bluher, University of Leipzig
- Investigators
- Matthias Blüher, prof., MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435057
- Sponsor's protocol ID
- STEN
- Status last verified
- May 2015
- First submitted
- 11 May 2011
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lehmann S, Retschlag U, Oberbach A, Morgenroth R, Linder N, Schaudinn A, Garnov N, Busse H, Solty K, Prettin C, Koppe-Bauernfeind N, Flehmig G, Selig L, Trips E, Stumvoll M, Petroff D, Bluher M. Visceral fat mass dynamics in a 2-year randomized STrength versus ENdurance training trial in people with obesity. Diabetes Obes Metab. 2024 Sep;26(9):4087-4099. doi: 10.1111/dom.15767. Epub 2024 Jul 16.
PubMed 39014526
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01435057
- Acronym / sponsor ID
- STEN
- Conditions
- Abdominal Obesity
- Keywords
- Abdominal Obesity, training, fat, insulin, glucose, diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endurance training | Active comparator | Procedure: exercise trainingEndurance 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. |
| strength training | Active comparator | Procedure: exercise trainingStrength 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI >= 35 kg/m2
- waist circumference >102cm (men), >88cm (women)
- age 18 - 60 years
- written informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise trainingcomparison of strength versus endurance training (two or three times a week, 60 minutes per training session) over 24 months | Procedure or surgery | endurance training, strength training |
Primary outcome
MRI
Time frame: Baseline and after 12 months after randomisation
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
8 secondary outcomes
MRI
Time frame: Baseline, 12 and 24 months after randomisation
BIA
Time frame: Baseline, 6, 12, 18 and 24 months after randomisation
compliance to the intervention
Time frame: over 24 months of intervention
well being as measured by SF-36
Time frame: Baseline and every 6 months during intervention
indirect calorimetry
Time frame: Baseline, 6, 12, 18 and 24 months after randomisation
fasting plasma glucose
Time frame: Baseline and every 12 months
inflammatory parameters
Time frame: Baseline and every 3 months during intervention
adipokine serum concentrations
Time frame: Baseline and every 3 months during intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 39014526Lehmann S, Retschlag U, Oberbach A, Morgenroth R, Linder N, Schaudinn A, Garnov N, Busse H, Solty K, Prettin C, Koppe-Bauernfeind N, Flehmig G, Selig L, Trips E, Stumvoll M, Petroff D, Bluher M. Visceral fat mass dynamics in a 2-year randomized STrength versus ENdurance training trial in people with obesity. Diabetes Obes Metab. 2024 Sep;26(9):4087-4099. doi: 10.1111/dom.15767. Epub 2024 Jul 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Blüher, prof., MD principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Abdominal Obesity, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Blüher, prof., MD (+493419715984, bluma@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI (time frame: Baseline and after 12 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01435057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.