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The aim of this study is to determine the effect of electroacupuncture on central obesity and fatty liver in postmenopausal women.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical treatment + Hypocaloric diet | Active Comparator | It will consist of thirty patients who will be treated by medical treatment in addition to hypocaloric diet (1,200 kcal/day) for 12 weeks. |
|
| Medical treatment + Hypocaloric diet + Electroacupuncture | Experimental | It will consist of twenty patients who will receive the same medical treatment and hypocaloric diet (1,200 kcal/day) as the active comparator group, in addition to electroacupuncture sessions administered three times per week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical treatment | Drug | All women in both groups will adhere to the same medication (orlistat) as prescribed by the gynecologist for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | 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. | 12 weeks |
| Waist Circumference | 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. | 12 weeks |
| Hip Circumference | Hip circumference will be assessed at the level of maximum circumference over the femoral trochanters. | 12 weeks |
| Waist-to-Hip Ratio (WHR) | 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. | 12 weeks |
| Serum Glutamic-Oxaloacetic Transaminase (SGOT / AST) | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol (TC) | 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Abdelhamid Elmaghawry Elgaedy, M.Sc | Contact | +201099430782 | Dr.mohamed_elgaedy@yahoo.com | |
| Doaa A. Osman, PhD | Contact | +201115792245 | Doaa.osman@cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Ahmed Mohamed Awad, PhD | Professor, Cairo University | Study Chair |
| Doaa A. Osman, PhD | Ass. Professor, Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Central Hospital | Aga | Egypt |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 5, 2025 | Feb 20, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000077403 | Orlistat |
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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|
| Hypocaloric diet | Other | 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. |
|
| Electroacupuncture | Other | 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. |
|
| Serum Glutamic-Pyruvic Transaminase (SGPT / ALT) |
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. |
| 12 weeks |
| Triglycerides (TG) |
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. |
| 12 weeks |
| Low-Density Lipoprotein Cholesterol (LDL) | 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. | 12 weeks |
| High-Density Lipoprotein Cholesterol (HDL) | 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. | 12 weeks |
| D015670 |
| Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |