AdiposityNCT02901496
Ectopic Adipose Tissue, Exercise Training and IL-6
A study testing Endurance Exercise Training, Resistance Exercise Training and No Exercise in people with Adiposity, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Aim: Exercise training improves the risk of cardiometabolic diseases; yet the underlying mechanisms are unclear. Exercise induces release of IL-6 from skeletal muscle. Acute elevations in IL-6 improve lipid and glucose metabolism, the latter partly through a delayed gastric emptying. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Adiposity
- What is being tested?
- Endurance Exercise Training, Resistance Exercise Training and No Exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to Apr 2018
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- Sedentary
- Waist to height ratio ≥ ½ and/or waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men)
- Age ≥ 18 y
Who cannot join
- Pregnancy
- Diagnosed with diabetes (HbA1c ≥ 48 mmol/mol or fasting glucose ≥ 7.0 mmol/l)
- Diagnosed with ischemic heart disease
- Atrial fibrillation
- Treatment with biologic rheumatic drugs, systemic prednisolone or other immunosuppressive treatments
- Health conditions that prevents individuals from participating in the exercise training intervention e.g. severe obesity
- Patients who cannot undergo MRI scans (e.g. kidney disease, metallic implants or claustrophobia)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Centre of Inflammation and Metabolism (CIM) Centre for Physical Activity Research (CFAS)
Copenhagen, 2100
About this study
Official title: The Role of Exercise Training Combined With Tocilizumab on Visceral and Epicardial Adipose Tissue and Gastric Emptying in a High Risk Population: an Exploratory Double-blind, Placebo-controlled Randomised Trial
Aim: Exercise training improves the risk of cardiometabolic diseases; yet the underlying mechanisms are unclear. Exercise induces release of IL-6 from skeletal muscle. Acute elevations in IL-6 improve lipid and glucose metabolism, the latter partly through a delayed gastric emptying. Physical inactivity causes accumulation of visceral fat (VAT). Visceral and epicardial adipose tissue (EAT) is more inflamed than subcutaneous adipose tissue. Thus, the investigators hypothesize that exercise-induced IL-6 mediates the exercise-induced reduction in EAT and VAT. Secondly, the investigators hypothesize that exercise-induced adaptations in glucose metabolism and gastric motility are dependent on IL-6. Finally the investigators hypothesise that both endurance and resistance exercise training reduce VAT and EAT.
Primary aim: To investigate the effects of exercise training on VAT and to determine to what extend IL-6 mediates this effect.
Read more
Secondary aims: 1) To determine whether 12 weeks of endurance and strength training can reduce the amount of EAT. 2) To study whether the effects of exercise on glucose metabolism and gastric emptying are dependent on IL-6.
Methods: Inclusion: 70 inactive men and women, >18 years, waist to height ratio > 0.5 and/or waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men) Design: A 12-week, double-blinded randomised, placebo-controlled exercise intervention study.
Intervention: Subjects will be randomised to one of five groups: i) Tocilizumab (IL-6 receptor antibody) and endurance training, ii) Placebo to Tocilizumab and endurance training, iii) Tocilizumab, no exercise iv) Placebo to Tocilizumab and no training, and v) Placebo to Tocilizumab, and resistance training. Tocilizumab/placebo dose will be administered (according to standard recommendations) before the first training session, and maintained during the 12-week training program. Training will be supervised to ensure intensity and compliance. Subjects will be instructed not to change eating habits and informed that this study does not aim for a weight loss.
Statistical considerations: Study investigators are blinded to treatment allocation. Dropouts will be replaced. A sample size of 70 subjects is needed to detect a 10% change in visceral adipose, with a power of 80% and a significance level of 0.05.
- Conditions
- Adiposity
- Being tested
- Endurance Exercise Training, Resistance Exercise Training, No Exercise, Tocilizumab, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance Exercise TrainingBehavioural
Also called Endurance exercise
Three months of supervised training. Interval training, 3 sessions weekly of 45 min. During intervals the intensity will be minimum 70 % of VO2 max
Resistance Exercise TrainingBehavioural
Also called Resistance exercise
Three months of supervised resistance training. Subjects will perform 3 weekly sessions of 45 min. The intensity will be kept at minimum 60% of 1RM.
No ExerciseBehavioural
Control to exercise
TocilizumabDrug
Also called RoActemra
Tocilizumab infusion will be administered monthly (8 mg/kg body weight i.v., maximun 800 mg). Each subject will receive 3 infusions during the study period.
PlaceboDrug
Also called Saline
Saline infusion will be administered monthly (same volume as Tocilizumab). Each subject will receive 3 infusions during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Endurance exercise + infusion of Tocilizumab | Experimental | Endurance exercise training + monthly infusion of Tocilizumab Receives: Behavioral: Endurance Exercise Training; Drug: Tocilizumab |
| Endurance exercise + infusion of placebo | Experimental | Endurance exercise training + monthly infusion of placebo Receives: Behavioral: Endurance Exercise Training; Drug: Placebo |
| No exercise + infusion of Tocilizumab | Experimental | No exercise + monthly infusion of Tocilizumab Receives: Behavioral: No Exercise; Drug: Tocilizumab |
| No exercise + infusion of placebo | Placebo comparator | No exercise training + monthly infusion of placebo Receives: Behavioral: No Exercise; Drug: Placebo |
| Resistance exercise + infusion of placebo | Experimental | Resistance exercise training + monthly infusion of placebo Receives: Behavioral: Resistance Exercise Training; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in visceral fat mass
Visceral fat mass will be measured by MRI before and after the intervention. Difference in change in visceral fat mass from baseline to 12 weeks follow up will be compared between group: Endurancetraining + tocilizumab and group: Endurancetraining + placebo.
Measured: 0, 12 weeks
Secondary outcomes (7)
Changes in visceral fat mass
Difference in change in visceral fat mass from baseline to 12 weeks follow up will be compared between group: Endurancetraining + placebo and group: no training + placebo.
Measured: 0, 12 weeks
Changes in visceral fat mass
- Difference in change in visceral fat mass from baseline to 12 weeks follow up will be compared between group: Endurancetraining + placebo and group: resistance training + placebo.
Measured: 0, 12 weeks
Changes in visceral fat mass
- Difference in change in visceral fat mass from baseline to 12 weeks follow up will be compared between group: Endurancetraining + tocilizumab and group: no training + tocilizumab.
Measured: 0, 12 weeks
Changes in visceral fat mass
- Difference in change in visceral fat mass from baseline to 12 weeks follow up will be compared between group: resistance training + placebo and group: no training + placebo.
Measured: 0, 12 weeks
Changes in visceral fat mass
- Difference in change in visceral fat mass from baseline to 12 weeks follow up will be compared between group: no training + placebo and group: no training + tocilizumab.
Measured: 0, 12 weeks
Epicardial adipose tissue
Cardiac fat volume will be measured by a cardiac MRI scan before and after the interventions. All groups will be compared.
Measured: 0, 12 weeks
Gastric emptying
Gastric emptying will be measured by paracetamol blood levels (mmol/l) before and after the interventions.
The paracetamol levels will be compared between groups as follows. Group: Endurancetraining + tocilizumab and group: Endurancetraining + placebo. Group: Endurancetraining + placebo and group: no training + placebo. Group: Endurancetraining + tocilizumab and group: no training + tocilizumab. Group: No training + placebo and group: no training + tocilizumab.
Measured: 0, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AdiposityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Lang Lehrskov, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bente K Pedersen, Professor, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901496
- Sponsor's protocol ID
- H-16018062
- Status last verified
- Jun 2022
- First submitted
- 1 Aug 2016
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wedell-Neergaard AS, Lang Lehrskov L, Christensen RH, Legaard GE, Dorph E, Larsen MK, Launbo N, Fagerlind SR, Seide SK, Nymand S, Ball M, Vinum N, Dahl CN, Henneberg M, Ried-Larsen M, Nybing JD, Christensen R, Rosenmeier JB, Karstoft K, Pedersen BK, Ellingsgaard H, Krogh-Madsen R. Exercise-Induced Changes in Visceral Adipose Tissue Mass Are Regulated by IL-6 Signaling: A Randomized Controlled Trial. Cell Metab. 2019 Apr 2;29(4):844-855.e3. doi: 10.1016/j.cmet.2018.12.007. Epub 2018 Dec 27.
PubMed 30595477Jonck S, Lok M, Durrer C, Wedell-Neergaard AS, Lehrskov LL, Legaard GE, Krogh-Madsen R, Rosenmeier J, Lund MAV, Pedersen BK, Ellingsgaard H, Berg RMG, Christensen RH. Exercise-induced changes in left ventricular strain are affected by interleukin-6 activity: An exploratory analysis of a randomised-controlled trial in humans with abdominal obesity. Exp Physiol. 2024 Jul;109(7):1134-1144. doi: 10.1113/EP091800. Epub 2024 May 27.
PubMed 38803062Christensen RH, Wedell-Neergaard AS, Lehrskov LL, Legaard GE, Dorph E, Larsen MK, Launbo N, Fagerlind SR, Seide SK, Nymand S, Ball M, Vinum NB, Dahl CN, Henneberg M, Ried-Larsen M, Boesen MP, Christensen R, Karstoft K, Krogh-Madsen R, Rosenmeier JB, Pedersen BK, Ellingsgaard H. Effect of Aerobic and Resistance Exercise on Cardiac Adipose Tissues: Secondary Analyses From a Randomized Clinical Trial. JAMA Cardiol. 2019 Aug 1;4(8):778-787. doi: 10.1001/jamacardio.2019.2074.
PubMed 31268469Christensen RH, Wedell-Neergaard AS, Lehrskov LL, Legard GE, Dorph EB, Nymand S, Ball MK, Zacho M, Christensen R, Ellingsgaard H, Rosenmeier JB, Krogh-Madsen R, Pedersen BK, Karstoft K. The role of exercise combined with tocilizumab in visceral and epicardial adipose tissue and gastric emptying rate in abdominally obese participants: protocol for a randomised controlled trial. Trials. 2018 May 2;19(1):266. doi: 10.1186/s13063-018-2637-0.
PubMed 29720225
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Exercise Training Combined With Tocilizumab on Visceral and Epicardial Adipose Tissue and Gastric Emptying in a High Risk Population: an Exploratory Double-blind, Placebo-controlled Randomised Trial
- ClinicalTrials.gov ID
- NCT02901496
- Acronym / sponsor ID
- H-16018062
- Conditions
- Adiposity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 15 Sep 2016 (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.
Aim: Exercise training improves the risk of cardiometabolic diseases; yet the underlying mechanisms are unclear. Exercise induces release of IL-6 from skeletal muscle. Acute elevations in IL-6 improve lipid and glucose metabolism, the latter partly through a delayed gastric emptying. Physical inactivity causes accumulation of visceral fat (VAT). Visceral and epicardial adipose tissue (EAT) is more inflamed than subcutaneous adipose tissue. Thus, the investigators hypothesize that exercise-induced IL-6 mediates the exercise-induced reduction in EAT and VAT. Secondly, the investigators hypothesize that exercise-induced adaptations in glucose metabolism and gastric motility are dependent on IL-6. Finally the investigators hypothesise that both endurance and resistance exercise training reduce VAT and EAT.
Primary aim: To investigate the effects of exercise training on VAT and to determine to what extend IL-6 mediates this effect.
Secondary aims: 1) To determine whether 12 weeks of endurance and strength training can reduce the amount of EAT. 2) To study whether the effects of exercise on glucose metabolism and gastric emptying are dependent on IL-6.
Methods: Inclusion: 70 inactive men and women, >18 years, waist to height ratio > 0.5 and/or waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men) Design: A 12-week, double-blinded randomised, placebo-controlled exercise intervention study.
Intervention: Subjects will be randomised to one of five groups: i) Tocilizumab (IL-6 receptor antibody) and endurance training, ii) Placebo to Tocilizumab and endurance training, iii) Tocilizumab, no exercise iv) Placebo to Tocilizumab and no training, and v) Placebo to Tocilizumab, and resistance training. Tocilizumab/placebo dose will be administered (according to standard recommendations) before the first training session, and maintained during the 12-week training program. Training will be supervised to ensure intensity and compliance. Subjects will be instructed not to change eating habits and informed that this study does not aim for a weight loss.
Statistical considerations: Study investigators are blinded to treatment allocation. Dropouts will be replaced. A sample size of 70 subjects is needed to detect a 10% change in visceral adipose, with a power of 80% and a significance level of 0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Endurance exercise + infusion of Tocilizumab | Experimental | Behavioral: Endurance Exercise Training, Drug: TocilizumabEndurance exercise training + monthly infusion of Tocilizumab |
| Endurance exercise + infusion of placebo | Experimental | Behavioral: Endurance Exercise Training, Drug: PlaceboEndurance exercise training + monthly infusion of placebo |
| No exercise + infusion of Tocilizumab | Experimental | Behavioral: No Exercise, Drug: TocilizumabNo exercise + monthly infusion of Tocilizumab |
| No exercise + infusion of placebo | Placebo comparator | Behavioral: No Exercise, Drug: PlaceboNo exercise training + monthly infusion of placebo |
| Resistance exercise + infusion of placebo | Experimental | Behavioral: Resistance Exercise Training, Drug: PlaceboResistance exercise training + monthly infusion of placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women
- Sedentary
- Waist to height ratio ≥ ½ and/or waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men)
- Age ≥ 18 y
Key exclusion criteria (7 listed)
- Pregnancy
- Diagnosed with diabetes (HbA1c ≥ 48 mmol/mol or fasting glucose ≥ 7.0 mmol/l)
- Diagnosed with ischemic heart disease
- Atrial fibrillation
- Treatment with biologic rheumatic drugs, systemic prednisolone or other immunosuppressive treatments
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 |
|---|---|---|
| Endurance Exercise TrainingAlso: Endurance exerciseThree months of supervised training. Interval training, 3 sessions weekly of 45 min. During intervals the intensity will be minimum 70 % of VO2 max | Behavioural | Endurance exercise + infusion of Tocilizumab, Endurance exercise + infusion of placebo |
| Resistance Exercise TrainingAlso: Resistance exerciseThree months of supervised resistance training. Subjects will perform 3 weekly sessions of 45 min. The intensity will be kept at minimum 60% of 1RM. | Behavioural | Resistance exercise + infusion of placebo |
| No ExerciseControl to exercise | Behavioural | No exercise + infusion of Tocilizumab, No exercise + infusion of placebo |
| TocilizumabAlso: RoActemraTocilizumab infusion will be administered monthly (8 mg/kg body weight i.v., maximun 800 mg). Each subject will receive 3 infusions during the study period. | Drug | Endurance exercise + infusion of Tocilizumab, No exercise + infusion of Tocilizumab |
| PlaceboAlso: SalineSaline infusion will be administered monthly (same volume as Tocilizumab). Each subject will receive 3 infusions during the study period. | Drug | Endurance exercise + infusion of placebo, No exercise + infusion of placebo, Resistance exercise + infusion of placebo |
Primary outcome
Changes in visceral fat mass
Time frame: 0, 12 weeks
Visceral fat mass will be measured by MRI before and after the intervention. Difference in change in visceral fat mass from baseline to 12 weeks follow up will be compared between group: Endurancetraining + tocilizumab and group: Endurancetraining + placebo.
7 secondary outcomes
Changes in visceral fat mass
Time frame: 0, 12 weeks
Changes in visceral fat mass
Time frame: 0, 12 weeks
Changes in visceral fat mass
Time frame: 0, 12 weeks
Changes in visceral fat mass
Time frame: 0, 12 weeks
Changes in visceral fat mass
Time frame: 0, 12 weeks
Epicardial adipose tissue
Time frame: 0, 12 weeks
Gastric emptying
Time frame: 0, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 30595477Wedell-Neergaard AS, Lang Lehrskov L, Christensen RH, Legaard GE, Dorph E, Larsen MK, Launbo N, Fagerlind SR, Seide SK, Nymand S, Ball M, Vinum N, Dahl CN, Henneberg M, Ried-Larsen M, Nybing JD, Christensen R, Rosenmeier JB, Karstoft K, Pedersen BK, Ellingsgaard H, Krogh-Madsen R. Exercise-Induced Changes in Visceral Adipose Tissue Mass Are Regulated by IL-6 Signaling: A Randomized Controlled Trial. Cell Metab. 2019 Apr 2;29(4):844-855.e3. doi: 10.1016/j.cmet.2018.12.007. Epub 2018 Dec 27.
- Derived from this study: PubMed 38803062Jonck S, Lok M, Durrer C, Wedell-Neergaard AS, Lehrskov LL, Legaard GE, Krogh-Madsen R, Rosenmeier J, Lund MAV, Pedersen BK, Ellingsgaard H, Berg RMG, Christensen RH. Exercise-induced changes in left ventricular strain are affected by interleukin-6 activity: An exploratory analysis of a randomised-controlled trial in humans with abdominal obesity. Exp Physiol. 2024 Jul;109(7):1134-1144. doi: 10.1113/EP091800. Epub 2024 May 27.
- Derived from this study: PubMed 31268469Christensen RH, Wedell-Neergaard AS, Lehrskov LL, Legaard GE, Dorph E, Larsen MK, Launbo N, Fagerlind SR, Seide SK, Nymand S, Ball M, Vinum NB, Dahl CN, Henneberg M, Ried-Larsen M, Boesen MP, Christensen R, Karstoft K, Krogh-Madsen R, Rosenmeier JB, Pedersen BK, Ellingsgaard H. Effect of Aerobic and Resistance Exercise on Cardiac Adipose Tissues: Secondary Analyses From a Randomized Clinical Trial. JAMA Cardiol. 2019 Aug 1;4(8):778-787. doi: 10.1001/jamacardio.2019.2074.
- Derived from this study: PubMed 29720225Christensen RH, Wedell-Neergaard AS, Lehrskov LL, Legard GE, Dorph EB, Nymand S, Ball MK, Zacho M, Christensen R, Ellingsgaard H, Rosenmeier JB, Krogh-Madsen R, Pedersen BK, Karstoft K. The role of exercise combined with tocilizumab in visceral and epicardial adipose tissue and gastric emptying rate in abdominally obese participants: protocol for a randomised controlled trial. Trials. 2018 May 2;19(1):266. doi: 10.1186/s13063-018-2637-0.
- Individual participant dataSharing planned: No
Related trials for Adiposity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruitingPhase 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1/2
Investigating the Effects of 24 Hour LEAP2 Infusion in Individuals With Overweight and Obesity
Obesity & Overweight
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.
Bente K Pedersen, Professor study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance Exercise Training, Resistance Exercise Training and No Exercise in people with Adiposity, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 7 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: finished, as of the sponsor's last update on 26 Feb 2024. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in visceral fat mass (time frame: 0, 12 weeks). 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 NCT02901496, which also lists 4 linked publications.
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 26 Feb 2024.