Effect of Electroacupuncture on Central Obesity and Fatty Liver in Postmenopausal Women

NCT07437001 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005973
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of electroacupuncture on central obesity and fatty liver in postmenopausal women.

Conditions

Postmenopausal Women

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Secondary Outcomes (4)

• Total Cholesterol (TC)

  12 weeks

• Triglycerides (TG)

  12 weeks

• Low-Density Lipoprotein Cholesterol (LDL)

  12 weeks

• High-Density Lipoprotein Cholesterol (HDL)

  12 weeks

Study Arms (2)

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.

Drug: Medical treatment; Other: Hypocaloric diet

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.

Drug: Medical treatment; Other: Hypocaloric diet; Other: Electroacupuncture

Interventions

Medical treatment DRUG

All women in both groups will adhere to the same medication (orlistat) as prescribed by the gynecologist for 12 weeks.

Also known as: orlistat

Medical treatment + Hypocaloric diet; Medical treatment + Hypocaloric diet + Electroacupuncture

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.

Medical treatment + Hypocaloric diet; Medical treatment + Hypocaloric diet + Electroacupuncture

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.

Medical treatment + Hypocaloric diet + Electroacupuncture

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Their ages will be ranged between 50 and 60 years old.
• Their body mass index will be ranged from 30-40 kg/m2.
• SGOT more 40 U/L.
• SGPT more 40 U/L.
• Waist/Hip Ratio more 1 cm.
• Triglyceride more 150 mg/dl.
• Cholesterol more 200 mg/dl.
• LDL more 100 mg/dl.
• HDL less 40 mg/dl.

You may not qualify if:

• Cancer.
• Concomitant cardiovascular disorders.
• Respiratory, renal and liver dysfunction.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Aga Central Hospital

Aga, Egypt

Location

MeSH Terms

Interventions

Orlistat; Electroacupuncture

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Mohamed Ahmed Mohamed Awad, PhD

  Professor, Cairo University

  STUDY CHAIR

• Doaa A. Osman, PhD

  Ass. Professor, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Abdelhamid Elmaghawry Elgaedy, M.Sc

CONTACT

+201099430782; Dr.mohamed_elgaedy@yahoo.com

Doaa A. Osman, PhD

CONTACT

+201115792245; Doaa.osman@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head OF physical therapy in AGA hospital

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

EG (1)