Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02339480
Other study ID # 20141021
Secondary ID
Status Completed
Phase N/A
First received January 13, 2015
Last updated August 8, 2017
Start date July 2015
Est. completion date March 2016

Study information

Verified date August 2017
Source Guiyang College of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date March 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Guiyang College of Troditional Chinese Medicine Gui Yang Guizhou

Sponsors (1)

Lead Sponsor Collaborator
Guiyang College of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other image of hypothalamus of functional magnetic resonance imaging (fMRI) before treatment and 6 weeks after treatment
Primary body mass index(BMI) 6 weeks after treatment
Secondary Body Weight 6 weeks after treatment
Secondary waistline 6 weeks after treatment
Secondary hip line 6 weeks after treatment
Secondary thigh line 6 weeks after treatment
Secondary percentage of body fat 6 weeks after treatment
See also
  Status Clinical Trial Phase
Completed NCT02494661 - Nutritional Video Intervention Using Mindfulness-based Principles N/A
Recruiting NCT03325179 - A Clinical Trial of Thread-embedding Therapy at Acupuncture Point for Simple Obesity N/A