Research on Mechanism of Massage Therapy on Energy Metabolism Disorder of Simple Obesity

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

Status

Completed

Conditions

Intervention / Treatment

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

    • Guizhou
      • Gui Yang, Guizhou, China, 550001
        • Guiyang College of Troditional Chinese Medicine

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:

  1. The individuals do not adhere to the treatment or are with other treatments.
  2. Secondary obesity, eg:pituitary diseases, hypothalamic disorder, hypothyroidism, pancreatic diseases,hyperadrenocorticism, postmenopausal obesity etc.
  3. Having therapy for obesity in the last two weeks.
  4. The individuals with server cardiovascular and cerebrovascular diseases and cancer.
  5. Critical patients or patients combined with liver and kidney damage.
  6. Individuals with psychosis.
  7. 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
No Intervention: Healthy volunteers
Healthy volunteers'hypothalamus picture of fMRI will compare with Obesity group' , no intervention and remaining unchanged lifestyle.
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
Healthy volunteers do not accept treatment, just to be a control group to compare with obesity group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
body mass index(BMI)
Time Frame: 6 weeks after treatment
6 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Body Weight
Time Frame: 6 weeks after treatment
6 weeks after treatment
waistline
Time Frame: 6 weeks after treatment
6 weeks after treatment
hip line
Time Frame: 6 weeks after treatment
6 weeks after treatment
thigh line
Time Frame: 6 weeks after treatment
6 weeks after treatment
percentage of body fat
Time Frame: 6 weeks after treatment
6 weeks after treatment

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
before treatment and 6 weeks after treatment

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

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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