Simple ObesityNCT02339480
Research on Mechanism of Massage Therapy on Energy Metabolism Disorder of Simple Obesity
A study testing Massage therapy in people with Simple Obesity, run by Guiyang College of Traditional Chinese Medicine at 1 site in China.
Trial summary
This project is to penetrate and consummate the research mechanism of massage therapy on simple obesity. Latest researches indicate that the energy regulation network system of hypothalamus and metabolic disorders on adipocyte may be the pathological bases which result in obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Simple Obesity
- What is being tested?
- Massage therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Mar 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.above 20% of the normal weight;BMI≥25.0；F%≥30%;
- 2.18-60 years old；
- 3.Patients agreeing and signing the Informed Consent for the study．
Who cannot join
- The individuals do not adhere to the treatment or are with other treatments.
- Secondary obesity, eg:pituitary diseases, hypothalamic disorder, hypothyroidism, pancreatic diseases，hyperadrenocorticism, postmenopausal obesity etc.
- Having therapy for obesity in the last two weeks.
- The individuals with server cardiovascular and cerebrovascular diseases and cancer.
- Critical patients or patients combined with liver and kidney damage.
- Individuals with psychosis.
- Female individuals with pregnancy, lactation and planning a pregnancy in the two months.
Trial locations and contacts
1 site in 1 country.
China1 site
Guiyang College of Troditional Chinese Medicine
Guiyang, Guizhou, 550001
About this study
This project is to penetrate and consummate the research mechanism of massage therapy on simple obesity. Latest researches indicate that the energy regulation network system of hypothalamus and metabolic disorders on adipocyte may be the pathological bases which result in obesity. The research group have firstly conducted effect studies of massage therapy on model of simple obesity rats and observed some neurobiological mechanism (whole effect mechanism), meanwhile, the team have discussed influences on the development of preadipocyte and function of endocrine with dynamic mechanical stimulation in vitro (local effect mechanism). This research aims at centering on the hypothesis that massage therapy can act on energy regulation network system of hypothalamus specifically, thus regulating the energy metabolic disorders. Then applying functional magnetic resonance imaging (fMRI) to explore whether patients with simple obesity exist abnormality on energy regulation network system of hypothalamus, ascertain mechanisms how massage therapy treat energy metabolism disorders of simple obesity, deepen mechanism study on how massage therapy prevent and treat obesity and enrich the clinical application's scientific connotation that massage therapy treat simple obesity.
Read the detailed description
This project will divide in two groups,healthy volunteers and obesity group.Healthy volunteers do not accept any treatment while obesity group need accept massage therapy three times a week,18 times in total.And two groups will be checked by functional magnetic resonance imaging (fMRI), Healthy volunteers for once and obesity group for twice(before treatment, obesity group's image of fMRI will compare with Healthy volunteers' and the image which is taken after treatment)
- Conditions
- Simple Obesity
- Being tested
- Massage therapy
- Keywords
- Massage therapy, Simple obesity, Energy metabolism, Mechanism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage therapyOther
Healthy volunteers do not accept treatment, just to be a control group to compare with obesity group
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | No intervention | Healthy volunteers'hypothalamus picture of fMRI will compare with Obesity group' , no intervention and remaining unchanged lifestyle. |
| Obesity group | Active comparator | An intervention group of patients is put on a waiting list for massage therapy.Observing the Curative effect and hypothalamus picture of fMRI compare with healthy volunteers Receives: Other: Massage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index(BMI)
Measured: 6 weeks after treatment
Secondary outcomes (5)
Body Weight
Measured: 6 weeks after treatment
waistline
Measured: 6 weeks after treatment
hip line
Measured: 6 weeks after treatment
thigh line
Measured: 6 weeks after treatment
percentage of body fat
Measured: 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simple 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guiyang College of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339480
- Sponsor's protocol ID
- 20141021
- Status last verified
- Aug 2017
- First submitted
- 13 Jan 2015
- Last updated
- 9 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Mechanism of Massage Therapy on Energy Metabolism Disorder of Simple Obesity
- ClinicalTrials.gov ID
- NCT02339480
- Acronym / sponsor ID
- 20141021
- Conditions
- Simple Obesity
- Keywords
- Massage therapy, Simple obesity, Energy metabolism, Mechanism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Guiyang College of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Jan 2015 (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.
This project is to penetrate and consummate the research mechanism of massage therapy on simple obesity. Latest researches indicate that the energy regulation network system of hypothalamus and metabolic disorders on adipocyte may be the pathological bases which result in obesity. The research group have firstly conducted effect studies of massage therapy on model of simple obesity rats and observed some neurobiological mechanism (whole effect mechanism), meanwhile, the team have discussed influences on the development of preadipocyte and function of endocrine with dynamic mechanical stimulation in vitro (local effect mechanism). This research aims at centering on the hypothesis that massage therapy can act on energy regulation network system of hypothalamus specifically, thus regulating the energy metabolic disorders. Then applying functional magnetic resonance imaging (fMRI) to explore whether patients with simple obesity exist abnormality on energy regulation network system of hypothalamus, ascertain mechanisms how massage therapy treat energy metabolism disorders of simple obesity, deepen mechanism study on how massage therapy prevent and treat obesity and enrich the clinical application's scientific connotation that massage therapy treat simple obesity.
Detailed description
This project will divide in two groups,healthy volunteers and obesity group.Healthy volunteers do not accept any treatment while obesity group need accept massage therapy three times a week,18 times in total.And two groups will be checked by functional magnetic resonance imaging (fMRI), Healthy volunteers for once and obesity group for twice(before treatment, obesity group's image of fMRI will compare with Healthy volunteers' and the image which is taken after treatment)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | No intervention | –Healthy volunteers'hypothalamus picture of fMRI will compare with Obesity group' , no intervention and remaining unchanged lifestyle. |
| Obesity group | Active comparator | Other: Massage therapyAn intervention group of patients is put on a waiting list for massage therapy.Observing the Curative effect and hypothalamus picture of fMRI compare with healthy volunteers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1.above 20% of the normal weight;BMI≥25.0；F%≥30%;
- 2.18-60 years old；
- 3.Patients agreeing and signing the Informed Consent for the study．
Key exclusion criteria (7 listed)
- The individuals do not adhere to the treatment or are with other treatments.
- Secondary obesity, eg:pituitary diseases, hypothalamic disorder, hypothyroidism, pancreatic diseases，hyperadrenocorticism, postmenopausal obesity etc.
- Having therapy for obesity in the last two weeks.
- The individuals with server cardiovascular and cerebrovascular diseases and cancer.
- Critical patients or patients combined with liver and kidney damage.
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 |
|---|---|---|
| Massage therapyHealthy volunteers do not accept treatment, just to be a control group to compare with obesity group | Other | Obesity group |
Primary outcome
body mass index(BMI)
Time frame: 6 weeks after treatment
5 secondary outcomes
Body Weight
Time frame: 6 weeks after treatment
waistline
Time frame: 6 weeks after treatment
hip line
Time frame: 6 weeks after treatment
thigh line
Time frame: 6 weeks after treatment
percentage of body fat
Time frame: 6 weeks after treatment
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 9 Aug 2017.
Related trials for Simple Obesity
Recruiting
Semaglutide and Tirzepatide for Genetic Aging Delay in Adults With Obesity
Adults With Simple Obesity
Not yet recruitingObservational study
Hormonal Impalance in Children With Simple Obesity
Children With Simple Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage therapy in people with Simple Obesity, run by Guiyang College of Traditional Chinese Medicine at 1 site in China.
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 3 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 9 Aug 2017. 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 China. 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?
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?
body mass index(BMI) (time frame: 6 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.