Postmenopausal WomenNCT07437001
Effect of Electroacupuncture on Central Obesity and Fatty Liver in Postmenopausal Women
A study testing Medical treatment, Hypocaloric diet and Electroacupuncture in people with Postmenopausal Women, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to determine the effect of electroacupuncture on central obesity and fatty liver in postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- Medical treatment, Hypocaloric diet and Electroacupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Their ages ranged between 50 and 60 years old.
- Their body mass index ranged from 30-40 kg/m2.
- Parity ranged from 2-3 times.
Who cannot join
- Cancer.
- Concomitant cardiovascular disorders.
- Respiratory, renal and liver dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Electroacupuncture on Central Obesity and Fatty Liver in Postmenopausal Women: A Randomized Controlled Trial
The aim of this study is to determine the effect of electroacupuncture on central obesity and fatty liver in postmenopausal women.
Read the detailed description
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.
- Conditions
- Postmenopausal Women
- Being tested
- Medical treatment, Hypocaloric diet, Electroacupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical treatmentDrug
Also called orlistat
All women in both groups will adhere to the same medication (orlistat) for 12 weeks.
Hypocaloric dietBehavioural
All women in both groups will be instructed to follow the same hypocaloric diet with a daily caloric intake of 1,200 kcal for a duration of 12 weeks.
ElectroacupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Medical treatment; Behavioral: 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. Receives: Drug: Medical treatment; Behavioral: Hypocaloric diet; Other: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 -80°C pending laboratory analysis.
Measured: 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 -80°C until analysis.
Measured: 12 weeks
Secondary outcomes (4)
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 -80°C until analysis. TC will be assessed using standardized enzymatic laboratory methods.
Measured: 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 -80°C until analysis.
Measured: 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 -80°C for subsequent laboratory analysis.
Measured: 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 -80°C.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026
- Primary completion1 Sep 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal WomenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel Hamid elgaedy, Cairo University
- Investigators
- Mohamed Ahmed Mohamed Awad, PhD, Study chair, Professor, Cairo UniversityDoaa A. Osman, PhD, Study director, Ass. Professor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437001
- Sponsor's protocol ID
- P.T.REC/012/005973
- Status last verified
- Oct 2026
- First submitted
- 22 Feb 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture on Central Obesity and Fatty Liver in Postmenopausal Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07437001
- Acronym / sponsor ID
- P.T.REC/012/005973
- Conditions
- Postmenopausal Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effect of electroacupuncture on central obesity and fatty liver in postmenopausal women.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical treatment + Hypocaloric diet | Active comparator | Drug: Medical treatment, Behavioral: Hypocaloric dietIt 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 | Drug: Medical treatment, Behavioral: Hypocaloric diet, Other: ElectroacupunctureIt 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. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Their ages ranged between 50 and 60 years old.
- Their body mass index ranged from 30-40 kg/m2.
- Parity ranged from 2-3 times.
Key exclusion criteria (3 listed)
- Cancer.
- Concomitant cardiovascular disorders.
- Respiratory, renal and liver dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical treatmentAlso: orlistatAll women in both groups will adhere to the same medication (orlistat) for 12 weeks. | Drug | Medical treatment + Hypocaloric diet, Medical treatment + Hypocaloric diet + Electroacupuncture |
| Hypocaloric dietAll women in both groups will be instructed to follow the same hypocaloric diet with a daily caloric intake of 1,200 kcal for a duration of 12 weeks. | Behavioural | Medical treatment + Hypocaloric diet, Medical treatment + Hypocaloric diet + Electroacupuncture |
| ElectroacupunctureWomen 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. | Other | Medical treatment + Hypocaloric diet + Electroacupuncture |
Primary outcome
Body Mass Index (BMI)
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.
Waist-to-Hip Ratio (WHR)
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.
Serum Glutamic-Oxaloacetic Transaminase (SGOT / AST)
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 -80°C pending laboratory analysis.
Serum Glutamic-Pyruvic Transaminase (SGPT / ALT)
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 -80°C until analysis.
4 secondary outcomes
Total Cholesterol (TC)
Time frame: 12 weeks
Triglycerides (TG)
Time frame: 12 weeks
Low-Density Lipoprotein Cholesterol (LDL)
Time frame: 12 weeks
High-Density Lipoprotein Cholesterol (HDL)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Ahmed Mohamed Awad, PhD study chair
Professor, Cairo University
Doaa A. Osman, PhD study director
Ass. Professor, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical treatment, Hypocaloric diet and Electroacupuncture in people with Postmenopausal Women, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.