Central Obesity Clinical Trial
Official title:
Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial
Verified date | March 2021 |
Source | Hong Kong Baptist University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.
Status | Completed |
Enrollment | 168 |
Est. completion date | February 28, 2021 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: Patients who meet all of the following criteria are defined as eligible participants: men and women aged between 18 and 65 years old; BMI = 25 kg/m2; central obesity, defined as WC of = 90 cm in men and = 80 cm in non-pregnant women according to ICD-10 [24]; not receiving any other weight control measures or any medical and/or drug history in last 3months. Exclusion Criteria: Patients who meet any of the following criteria should be excluded from the study: endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating women; impaired hepatic or renal function; stroke or unable to exercise. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Linda Zhong | Kowloon Tong | Kowloon |
Lead Sponsor | Collaborator |
---|---|
Hong Kong Baptist University | Princess Margaret Hospital, Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in waist circumference | Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button). | 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks | |
Secondary | Changes in hip circumference | hip circumference measured at the level of maximum posterior extension of the buttocks | 0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks | |
Secondary | Adverse events after treatment and follow up | Adverse events of acupuncture treatment will be assessed using the Treatment Emergent Symptom Scale (TESS) and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study. | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks | |
Secondary | Changes in waist-to-hip circumference ratio | waist-to-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W รท H ). | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks | |
Secondary | Changes in Body Mass Index | Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks | |
Secondary | Changes in body fat percentage | The body fat percentage (BFP) of a human or other living being is the total mass of fat divided by total body mass, multiplied by 100. Body fat percentage will be measured by Omron Karada Scan HBF-701. | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks | |
Secondary | Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) | Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment. | 0, 8 weeks |
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