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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-60
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Cancer.

Concomitant cardiovascular disorders.

Respiratory, renal and liver dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medical treatment

    Drug

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

  • Hypocaloric diet

    Other intervention

    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 intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Medical treatment + Hypocaloric dietActive comparator 2 interventions
Group B: Medical treatment + Hypocaloric diet + ElectroacupunctureExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

Hip Circumference

Hip circumference will be assessed at the level of maximum circumference over the femoral trochanters.

Time frame
12 weeks
4

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.

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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.

Time frame
12 weeks
4

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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