NCT02339480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

January 13, 2015

Last Update Submit

August 8, 2017

Conditions

Simple Obesity

Keywords

Massage therapySimple obesityEnergy metabolismMechanism

Outcome Measures

Primary Outcomes (1)

  • body mass index(BMI)

    6 weeks after treatment

Secondary Outcomes (5)

  • Body Weight

    6 weeks after treatment

  • waistline

    6 weeks after treatment

  • hip line

    6 weeks after treatment

  • thigh line

    6 weeks after treatment

  • percentage of body fat

    6 weeks after treatment

Other Outcomes (1)

  • image of hypothalamus of functional magnetic resonance imaging (fMRI)

    before treatment and 6 weeks after treatment

Study Arms (2)

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

Other: Massage therapy

Interventions

Massage therapyOTHER

Healthy volunteers do not accept treatment, just to be a control group to compare with obesity group

Obesity group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • above 20% of the normal weight;BMI≥25.0；F%≥30%;
  • years old；
  • Patients agreeing and signing the Informed Consent for the study．

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guiyang College of Troditional Chinese Medicine

Guiyang, Guizhou, 550001, China

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 15, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

CN(1)