Research on Mechanism of Massage Therapy on Energy Metabolism Disorder of Simple Obesity
Primary Purpose
Simple Obesity
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Massage therapy
Sponsored by
About this trial
This is an interventional basic science trial for Simple Obesity focused on measuring Massage therapy, Simple obesity, Energy metabolism, Mechanism
Eligibility Criteria
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.
Sites / Locations
- Guiyang College of Troditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Healthy volunteers
Obesity group
Arm Description
Healthy volunteers'hypothalamus picture of fMRI will compare with Obesity group' , no intervention and remaining unchanged lifestyle.
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
Outcomes
Primary Outcome Measures
body mass index(BMI)
Secondary Outcome Measures
Body Weight
waistline
hip line
thigh line
percentage of body fat
Full Information
NCT ID
NCT02339480
First Posted
January 13, 2015
Last Updated
August 8, 2017
Sponsor
Guiyang College of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02339480
Brief Title
Research on Mechanism of Massage Therapy on Energy Metabolism Disorder of Simple Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guiyang College of Traditional Chinese Medicine
4. Oversight
5. Study Description
Brief 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. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Simple Obesity
Keywords
Massage therapy, Simple obesity, Energy metabolism, Mechanism
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
No Intervention
Arm Description
Healthy volunteers'hypothalamus picture of fMRI will compare with Obesity group' , no intervention and remaining unchanged lifestyle.
Arm Title
Obesity group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Massage therapy
Intervention Description
Healthy volunteers do not accept treatment, just to be a control group to compare with obesity group
Primary Outcome Measure Information:
Title
body mass index(BMI)
Time Frame
6 weeks after treatment
Secondary Outcome Measure Information:
Title
Body Weight
Time Frame
6 weeks after treatment
Title
waistline
Time Frame
6 weeks after treatment
Title
hip line
Time Frame
6 weeks after treatment
Title
thigh line
Time Frame
6 weeks after treatment
Title
percentage of body fat
Time Frame
6 weeks after treatment
Other Pre-specified Outcome Measures:
Title
image of hypothalamus of functional magnetic resonance imaging (fMRI)
Time Frame
before treatment and 6 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Guiyang College of Troditional Chinese Medicine
City
Gui Yang
State/Province
Guizhou
ZIP/Postal Code
550001
Country
China
12. IPD Sharing Statement
Learn more about this trial
Research on Mechanism of Massage Therapy on Energy Metabolism Disorder of Simple Obesity
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