Abdominal ObesityNCT02427347
Acupuncture in the Regulation of Dai Meridian for the Metabolism of Visceral Adipose Tissue in Abdominal Obese Patients
A study testing Acupuncture and Healthy education in people with Abdominal Obesity and Metabolic Syndrome, run by Dongfang Hospital Beijing University of Chinese Medicine at 1 site in China.
Trial summary
To evaluate the effectiveness of acupuncture therapy combined with healthy education for patients with abdominal obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Abdominal Obesity, Metabolic Syndrome
- What is being tested?
- Acupuncture and Healthy education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Met the diagnostic criteria of abdominal obesity (waist circumference of male ≥ 90cm, waist circumference of female ≥ 80cm);
- Ultrasound viscerofatty index ≥ 3;
- Age between 18-70 years old;
- Signed informed consent voluntarily.
Who cannot join
- Secondary obesity caused by endocrine, hereditary, nervous system,or drugs;
- Within 3 months adjusted drug therapy for diabetes or hypertension or hyperlipidemia;
- undergoing other therapies for reducing body mass and waist circumference, such as surgery, medication, etc;
- participating or have participated in other studies;
- pregnant or breast-feeding women;
- critically ill, having hepatic-renal dysfunction or mental illness;
- severe impairment in sight and hearing.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078
About this study
Official title: A Randomized Controlled Clinical Trial of Acupuncture on Regulating Dai Meridian for Visceral Fat Metabolism in Abdominal Obesity.
To evaluate the effectiveness of acupuncture therapy combined with healthy education for patients with abdominal obesity.
Read the detailed description
This subject is a prospective, single-blind, parallel-group, randomized controlled clinical trial.120 patients with abdominal obesity are allocated into two groups with a ratio of 2:1.Randomized series was generated by computer. The allocation was concealed. Patients in the intervention group are received acupuncture therapy and healthy education. Patients in the control group are only given healthy education. The treatment in both intervention group and control group lasts for 8 weeks. Comparison of two groups of patients with abdominal fat thickness, fasting serum visfatin concentration, simple anthropometric parameters (including body weight, body mass index, waist circumference, hip circumference, waist-to-hip radio, waist-to-height radio, the percentage of body fat), fasting blood glucose, fasting insulin, glycosylated hemoglobin, fasting blood lipid (total cholesterol, triglyceride, high density lipoprotein, low density lipoprotein), uric acid, blood pressure, insulin resistance level, and obesity related lifestyle survey.
- Conditions
- Abdominal Obesity, Metabolic Syndrome
- Being tested
- Acupuncture, Healthy education
- Medical subject headings
- Obesity, Abdominal, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture needles of 0.3mm in diameter and 100mm in length are inserted into gallbladder-meridian(GB)26 about 25-65mm deep by an angle of 15°, following the path of Dai Meridian (towards medial and downside) . The other acupoints are inserted with needles of 0.25-0.3mm in diameter and 25-40mm in length approximately 10-30mm deep, with an angle of 90°. Electro-acupuncture is applied to both sides of GB26 and stomach-meridian(ST)25: cathode is connected to GB26; anode to ST25. Dense-disperse wave pattern and a wave frequency of 2/100 Hertz is chosen. The intensity of the electro-acupuncture is adjusted on average 4-8 milliampere. The needles are subsequently retained for 20min. The results of the study are based on 8 weeks, each week consisting of 3 sessions.
Healthy educationOther
Healthy knowledge lectures and issuing brochures are given. Education of patients for conditioning and changing bad habits, diet, quit smoking, limit alcohol consumption, salt restriction, appropriate increase in physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention including acupuncture treatment and healthy education. Receives: Other: Acupuncture; Other: Healthy education |
| Control group | Other | Healthy education is given as a baseline treatment. Receives: Other: Healthy education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in abdominal subcutaneous fat thickness at 8 weeks
Including subcutaneous fat thickness 1 and 2
Measured: baseline and 8 weeks
Changes from Baseline in abdominal visceral fat thickness at 8 weeks
Including visceral fat thickness 1 and 2
Measured: baseline and 8 weeks
Change from Baseline in antero-hepatic fat thickness at 8 weeks
Antero-hepatic fat thickness (AHF) was determined by the distance of peritoneum to the hepatic cortex at the subcostal level.
Measured: baseline and 8 weeks
Change from Baseline in perirenal fat thickness at 8 weeks
Perirenal fat thickness (PRF) was determined by the thickest one of the perirenal fat capsule of the right kidney short axis, when the right renal short axis and the maximum width of the renal sinus were clearly displayed.
Measured: baseline and 8 weeks
Change from Baseline in ultrasound viscerofatty index at 8 weeks
ultrasound viscerofatty index (UVI) = (visceral fat thickness 1 + visceral fat thickness2)/(subcutaneous fat thickness 1 + subcutaneous fat thickness 2)
Measured: baseline and 8 weeks
Change from Baseline in fasting serum visfatin at 8 weeks
5ml venous blood was told after an 8 hours fast. Visfatin was measured by enzyme-linkedimmuno sorbent assay (ELISA).
Measured: baseline and 8 weeks
Secondary outcomes (18)
Change from Baseline in body weight
It's made at the situation of fasting, after emptying bowels, with minimal clothing, without headdress and footwear, at the end of expiration.
Measured: baseline, 4 weeks and 8 weeks
Change from Baseline in body mass index
Body mass index (BMI) = body weight(kg)/height(m)/height(m)
Measured: baseline, 4 weeks and 8 weeks
Change from Baseline in waist circumference
WC was measured at the level between the inferior portion of 12th rib and iliac crest.
Measured: baseline, 4 weeks and 8 weeks
Change from Baseline in hip circumference
HC was measured at the level of the most prominent point of the pelvis.
Measured: baseline, 4 weeks and 8 weeks
Change from Baseline in waist-to-hip radio
waist-to-hip radio (WHR) = waist circumference(cm)/hip circumference(cm)
Measured: baseline, 4 weeks and 8 weeks
Change from Baseline in waist-to-height radio
waist-to-height radio (WHtR) = waist circumference(cm)/height(cm)
Measured: baseline, 4 weeks and 8 weeks
Change from Baseline in the percentage of body fat
the percentage of body fat = 1.2×BMI+0.23×age-5.4-10.8×gender（M=1，F=0）
Measured: baseline, 4 weeks and 8 weeks
Change from Baseline in fasting blood glucose at 8 weeks
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Measured: baseline and 8 weeks
Change from Baseline in fasting insulin at 8 weeks
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Measured: baseline and 8 weeks
Change from Baseline in glycosylated hemoglobin at 8 weeks
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Measured: baseline and 8 weeks
Change from Baseline in fasting total cholesterol at 8 weeks
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Measured: baseline and 8 weeks
Change from Baseline in fasting triglyceride at 8 weeks
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Measured: baseline and 8 weeks
Change from Baseline in fasting high density lipoprotein cholesterol at 8 weeks
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Measured: baseline and 8 weeks
Change from Baseline in fasting low density lipoprotein cholesterol at 8 weeks
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Measured: baseline and 8 weeks
Change from Baseline in fasting uric acid at 8 weeks
5ml venous blood was collected after an 8 hours fast. It was tested by our hospital's laboratory.
Measured: baseline and 8 weeks
Change from Baseline in blood pressure at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in insulin resistance level at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in obesity related lifestyle survey at 8 weeks
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission, Beijing University of Chinese Medicine
- Responsible party
- Principal investigator, Hui Hu, Dongfang Hospital Beijing University of Chinese Medicine
- Investigators
- Hui Hu, doctor, Study chair, Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427347
- Sponsor's protocol ID
- Z141107002514079
- Status last verified
- Aug 2018
- First submitted
- 13 Apr 2015
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Acupuncture on Regulating Dai Meridian for Visceral Fat Metabolism in Abdominal Obesity.
- ClinicalTrials.gov ID
- NCT02427347
- Acronym / sponsor ID
- Z141107002514079
- Conditions
- Abdominal Obesity, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission, Beijing University of Chinese Medicine
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of acupuncture therapy combined with healthy education for patients with abdominal obesity.
Detailed description
This subject is a prospective, single-blind, parallel-group, randomized controlled clinical trial.120 patients with abdominal obesity are allocated into two groups with a ratio of 2:1.Randomized series was generated by computer. The allocation was concealed. Patients in the intervention group are received acupuncture therapy and healthy education. Patients in the control group are only given healthy education. The treatment in both intervention group and control group lasts for 8 weeks. Comparison of two groups of patients with abdominal fat thickness, fasting serum visfatin concentration, simple anthropometric parameters (including body weight, body mass index, waist circumference, hip circumference, waist-to-hip radio, waist-to-height radio, the percentage of body fat), fasting blood glucose, fasting insulin, glycosylated hemoglobin, fasting blood lipid (total cholesterol, triglyceride, high density lipoprotein, low density lipoprotein), uric acid, blood pressure, insulin resistance level, and obesity related lifestyle survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Acupuncture, Other: Healthy educationIntervention including acupuncture treatment and healthy education. |
| Control group | Other | Other: Healthy educationHealthy education is given as a baseline treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Met the diagnostic criteria of abdominal obesity (waist circumference of male ≥ 90cm, waist circumference of female ≥ 80cm);
- Ultrasound viscerofatty index ≥ 3;
- Age between 18-70 years old;
- Signed informed consent voluntarily.
Key exclusion criteria (7 listed)
- Secondary obesity caused by endocrine, hereditary, nervous system,or drugs;
- Within 3 months adjusted drug therapy for diabetes or hypertension or hyperlipidemia;
- undergoing other therapies for reducing body mass and waist circumference, such as surgery, medication, etc;
- participating or have participated in other studies;
- pregnant or breast-feeding women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture needles of 0.3mm in diameter and 100mm in length are inserted into gallbladder-meridian(GB)26 about 25-65mm deep by an angle of 15°, following the path of Dai Meridian (towards medial and downside) . The other acupoints are inserted with needles of 0.25-0.3mm in diameter and 25-40mm in length approximately 10-30mm deep, with an angle of 90°. Electro-acupuncture is applied to both sides of GB26 and stomach-meridian(ST)25: cathode is connected to GB26; anode to ST25. Dense-disperse wave pattern and a wave frequency of 2/100 Hertz is chosen. The intensity of the electro-acupuncture is adjusted on average 4-8 milliampere. The needles are subsequently retained for 20min. The results of the study are based on 8 weeks, each week consisting of 3 sessions. | Other | Intervention group |
| Healthy educationHealthy knowledge lectures and issuing brochures are given. Education of patients for conditioning and changing bad habits, diet, quit smoking, limit alcohol consumption, salt restriction, appropriate increase in physical activity. | Other | Control group, Intervention group |
Primary outcome
Changes from Baseline in abdominal subcutaneous fat thickness at 8 weeks
Time frame: baseline and 8 weeks
Including subcutaneous fat thickness 1 and 2
Changes from Baseline in abdominal visceral fat thickness at 8 weeks
Time frame: baseline and 8 weeks
Including visceral fat thickness 1 and 2
Change from Baseline in antero-hepatic fat thickness at 8 weeks
Time frame: baseline and 8 weeks
Antero-hepatic fat thickness (AHF) was determined by the distance of peritoneum to the hepatic cortex at the subcostal level.
Change from Baseline in perirenal fat thickness at 8 weeks
Time frame: baseline and 8 weeks
Perirenal fat thickness (PRF) was determined by the thickest one of the perirenal fat capsule of the right kidney short axis, when the right renal short axis and the maximum width of the renal sinus were clearly displayed.
Change from Baseline in ultrasound viscerofatty index at 8 weeks
Time frame: baseline and 8 weeks
ultrasound viscerofatty index (UVI) = (visceral fat thickness 1 + visceral fat thickness2)/(subcutaneous fat thickness 1 + subcutaneous fat thickness 2)
Change from Baseline in fasting serum visfatin at 8 weeks
Time frame: baseline and 8 weeks
5ml venous blood was told after an 8 hours fast. Visfatin was measured by enzyme-linkedimmuno sorbent assay (ELISA).
18 secondary outcomes
Change from Baseline in body weight
Time frame: baseline, 4 weeks and 8 weeks
Change from Baseline in body mass index
Time frame: baseline, 4 weeks and 8 weeks
Change from Baseline in waist circumference
Time frame: baseline, 4 weeks and 8 weeks
Change from Baseline in hip circumference
Time frame: baseline, 4 weeks and 8 weeks
Change from Baseline in waist-to-hip radio
Time frame: baseline, 4 weeks and 8 weeks
Change from Baseline in waist-to-height radio
Time frame: baseline, 4 weeks and 8 weeks
Change from Baseline in the percentage of body fat
Time frame: baseline, 4 weeks and 8 weeks
Change from Baseline in fasting blood glucose at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in fasting insulin at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in glycosylated hemoglobin at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in fasting total cholesterol at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in fasting triglyceride at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in fasting high density lipoprotein cholesterol at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in fasting low density lipoprotein cholesterol at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in fasting uric acid at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in blood pressure at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in insulin resistance level at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in obesity related lifestyle survey at 8 weeks
Time frame: baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Hu, doctor study chair
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Healthy education in people with Abdominal Obesity and Metabolic Syndrome, run by Dongfang Hospital Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline in abdominal subcutaneous fat thickness at 8 weeks (time frame: baseline and 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.