- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02339480
Research on Mechanism of Massage Therapy on Energy Metabolism Disorder of Simple Obesity
August 8, 2017 updated by: Guiyang College of Traditional Chinese Medicine
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guizhou
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Gui Yang, Guizhou, China, 550001
- Guiyang College of Troditional Chinese Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Healthy volunteers
Healthy volunteers'hypothalamus picture of fMRI will compare with Obesity group' , no intervention and remaining unchanged lifestyle.
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Active Comparator: Obesity group
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
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Healthy volunteers do not accept treatment, just to be a control group to compare with obesity group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
body mass index(BMI)
Time Frame: 6 weeks after treatment
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6 weeks after treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body Weight
Time Frame: 6 weeks after treatment
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6 weeks after treatment
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waistline
Time Frame: 6 weeks after treatment
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6 weeks after treatment
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hip line
Time Frame: 6 weeks after treatment
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6 weeks after treatment
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thigh line
Time Frame: 6 weeks after treatment
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6 weeks after treatment
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percentage of body fat
Time Frame: 6 weeks after treatment
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6 weeks after treatment
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
image of hypothalamus of functional magnetic resonance imaging (fMRI)
Time Frame: before treatment and 6 weeks after treatment
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before treatment and 6 weeks after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
January 13, 2015
First Submitted That Met QC Criteria
January 14, 2015
First Posted (Estimate)
January 15, 2015
Study Record Updates
Last Update Posted (Actual)
August 9, 2017
Last Update Submitted That Met QC Criteria
August 8, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20141021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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