Aga Central Hospital
Aga, Egypt
NCT Number: NCT07437001
The aim of this study is to determine the effect of electroacupuncture on central obesity and fatty liver in postmenopausal women.
Trial opening soon.
Get Notified50 year–60 year
Female
Interventional
Not applicable
Aga, Egypt
Post menopause is the time after you've been without a menstrual period for 12 months. It lasts for the rest of your life. During this stage, menopausal symptoms, such as hot flashes, get milder or go away.
Electro-acupuncture has a major advantage that it's the margin of error in needle placement for electro-acupuncture is greater than for manual therapy and therefore a less accurate placement is required, as the current spreads and may reach a nerve several millimeters away.
In electro-acupuncture, the therapist inserts the acupuncture needles in acupuncture points and electric current is connected to the body through the acupuncture needles.
Electro-acupuncture treatment helps in decreasing blood lipids in patients with fatty liver disease and plays a significant role in improving the immunity system in patients with hepatitis in addition to improving their clinical symptoms. Previous clinical studies in China indicated that electro-acupuncture able to decrease total cholesterol (TC), triglycerides (TG), low-density lipoproteins (LDL), and elevate high-density lipoproteins (HDL) in patients suffering from dyslipidemia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All women in both groups will adhere to the same medication (orlistat) as prescribed by the gynecologist for 12 weeks.
Other names: orlistat
All women in both groups will be instructed to follow the same hypocaloric diet, as prescribed by a certified nutrition specialist, with a daily caloric intake of 1,200 kcal for a duration of 12 weeks.
Women in the experimental group only will undergo electroacupuncture three times per week for 12 weeks. Treatment will be delivered in the supine position using sterile needles inserted at eight standardized acupoints associated with central obesity and weight regulation, with insertion depths of 10-25 mm. Low-frequency electrical stimulation (2 Hz, 0.5 ms) will be applied to the abdominal region for 30 minutes per session.
Time frame: 12 weeks
BMI will be calculated as weight in kilograms divided by height in meters squared (kg/m²). Height will be measured using a stadiometer, and BMI will be assessed at baseline and post-intervention. BMI serves as a primary outcome as it provides a standardized indicator of overall obesity and treatment-related changes in adiposity.
Time frame: 12 weeks
Waist circumference will be measured at the narrowest point between the xiphoid process and the iliac crest at the end of gentle expiration, with participants standing. This measure directly reflects central obesity and is therefore considered a primary outcome.
Time frame: 12 weeks
Hip circumference will be assessed at the level of maximum circumference over the femoral trochanters.
Time frame: 12 weeks
WHR will be calculated by dividing waist circumference by hip circumference. This index reflects fat distribution and cardiometabolic risk, making it a primary outcome for central obesity assessment.
Time frame: 12 weeks
In the context of fatty liver disease, elevated SGOT levels reflect the degree of hepatic inflammation and cellular stress associated with lipid accumulation within hepatocytes. This biomarker will be measured from venous blood samples collected from the antecubital fossa of each participant at baseline and following the completion of the 12-week intervention. Samples will undergo centrifugation within eight hours of collection, with serum preserved at -20°C pending laboratory analysis.
Time frame: 12 weeks
Elevated SGPT activity in the serum is considered a hallmark biochemical indicator of non-alcoholic fatty liver disease (NAFLD), the hepatic manifestation most commonly associated with central obesity and insulin resistance in postmenopausal women. Blood samples will be drawn from the antecubital vein of each participant before and after the 12-week treatment period, centrifuged within eight hours of collection, and the resulting serum stored at -20°C until analysis.
Time frame: 12 weeks
Fasting venous blood samples will be collected from the antecubital vein at baseline and after the 12-week intervention period. Serum will be separated by centrifugation within 8 hours and stored at -20°C until analysis. TC will be assessed using standardized enzymatic laboratory methods.
Time frame: 12 weeks
TC will be quantified from serum samples obtained via antecubital venipuncture before and after the 12-week treatment program. Samples will be centrifuged within eight hours of collection and stored at -20°C until analysis.
Time frame: 12 weeks
LDL levels will be determined from serum samples drawn from the antecubital fossa of each participant prior to and following the 12-week intervention period. Collected samples will be centrifuged within eight hours and preserved at -20°C for subsequent laboratory analysis.
Time frame: 12 weeks
HDL-C will be quantified from venous blood samples collected at the antecubital fossa before and after the 12-week electroacupuncture protocol, following centrifugation within eight hours and storage at -20°C.
Contact information is provided by the study sponsor or research team.
Doaa A. Osman, PhD
CONTACT
Mohamed Abdelhamid Elmaghawry Elgaedy, M.Sc
CONTACT
Cairo University
Other
Effect of Electroacupuncture on Central Obesity and Fatty Liver in Postmenopausal Women: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07650175
Balance, Postmenopausal Women
View Trial DetailsNCT07366632
Postmenopausal Women
View Trial DetailsNCT07186985
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
View Trial DetailsNCT07731711
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Kafr ash Shaykh, Kafrelsheikh, Egypt
View Trial Details