Polycystic Ovary SyndromeNCT06549647
Effect of Laser Acupuncture on Insulin Resistance in Obese Women With Polycystic Ovarian Syndrome
A study testing low caloric diet and Laser Acupuncture in people with Polycystic Ovary Syndrome, run by Cairo University.
Trial summary
This study will be conducted to investigate the effect of laser acupuncture on insulin resistance in obese women with polycystic ovarian syndrome. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- low caloric diet and Laser Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2024to 20 Dec 2024
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Forty obese women with PCOS as clinically diagnosed by gynecologist.
- Their ages will be ranged from 20 to 35 years old.
- Their BMI will be ranged from 30-40 kg/m2
- Their waist/hip ratio will be >0.8
- All of them should have at least two criteria of the Rotterdam diagnostic criteria of PCOS.
Who cannot join
- Cushing syndrome, diabetes mellitus, Thyroid dysfunction, Hypothalamic amenorrhea, Ovarian hyperplasia
- Respiratory, renal and liver dysfunction.
- Skin diseases and any other condition that may prevent the usage of laser (skin cancer, active acne and skin infections).
- Malignancy
Trial locations and contacts
No sites are listed yet.
Manal Ahmed El-Shafei, PhD contact
About this study
This study will be conducted to investigate the effect of laser acupuncture on insulin resistance in obese women with polycystic ovarian syndrome.
Read the detailed description
Women with Polycystic Ovary Syndrome (PCOS) face an increased risk of various health issues, including glucose intolerance, type 2 diabetes, hypertension, dyslipidemia, and subfertility. The prevalence of insulin resistance (IR) in PCOS can range from 44% to 70%, with longitudinal studies indicating that worsening IR over time in obese women with PCOS is associated with an increased risk of early-onset type 2 diabetes.
Conventional interventions, such as oral contraceptives, metformin, and hormonal therapy, have been developed to address the effects of PCOS. However, these treatments can have adverse side effects, including an increased risk of estrogen-related cancers. Consequently, lifestyle modifications to prevent aberrant immune activation and minimize exposure to inflammatory agents have emerged as a more sustainable approach.
Emerging evidence suggests the potential of alternative physical therapy modalities, such as transcutaneous electrical nerve stimulation, electro-acupuncture, and laser acupuncture, in managing PCOS. Laser acupuncture, in particular, has been shown to reduce sympathetic activity, decrease ovarian androgen release, and modulate the activity of higher centers, ultimately influencing gonadotropin-releasing hormone secretion and the menstrual cycle. Additionally, laser acupuncture may reduce the levels of pro-inflammatory cytokines, which contribute to insulin resistance and atherosclerosis.
While a few studies have investigated the effects of laser acupuncture on insulin resistance in obese women with PCOS, further research is needed to provide deeper insights into the benefits of this intervention and its role in managing insulin resistance in this population, which could expand the clinical applications of laser therapy in physical therapy.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- low caloric diet, Placebo laser acupoint stimulation, Laser Acupuncture
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low caloric dietOther
A low caloric diet of 1200 Kcal will be followed by participant for 3 months. The dietary intervention follows a macronutrient ratio of 15% protein, 30% fat, and 55% carbohydrates. Participants are advised to consume 170-240g of complex carbohydrates, 60-100g of fat, and 55-93g of protein per day, with 20-35g of fiber. Patients are also advised to limit salt, tea, and caffeine intake, and receive supplemental vitamins to prevent deficiencies.
Placebo laser acupoint stimulationOther
Placebo laser acupoint stimulation will be used for all participants in group (A).
Laser AcupunctureOther
Eazyone EZ1 level laser will be used for the treatment procedures for all participants in group (B) only. Every participant in group (B) will be instructed briefly about the effect of laser acupoints therapy to gain her confidence and co-operation. It will be applied with infrared laser with 830 nm wavelength, 5 W power output and 0.5 J energy on the following acupoints while the patient lie in supine lying position. The head of the machine will be applied perpendicularly on each point for 1 min (17 min total), 3 times/ week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo laser on acpoints + low caloric diet | Placebo comparator | It will be consisted of 20 obese women diagnosed as having PCOS. Each will receive placebo laser on acupoints (3 sessions/week, 17 minutes/ session) in addition to low caloric diet for 3 months. Receives: Other: low caloric diet; Other: Placebo laser acupoint stimulation |
| Laser acupuncture + low caloric diet | Experimental | It will be consisted of 20 obese women diagnosed as having PCOS who will receive the same low caloric diet as in group (A) in addition to application of laser acupuncture on (REN 4,5), (ST 25,29,36,40), (CV 3,6,10,12),(SP 6), (L14), 1 minutes for each points (17 minutes/session), 3 times/week for 3 months. Receives: Other: low caloric diet; Other: Laser Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI)
It will be calculated from the weight and height of each participant in both groups (A\&B), before beginning of the study and after end of the study program, according to the following equation:
BMI =(Weight (kg))/(Height square (m²)) kg/m²
Measured: 3 months
Waist/hip ratio
It will be calculated from the waist and hip circumferences for all participants in both groups (A\&B) according to the equation waist/hip ratio= (waist / hip) before and after the end of study.
Measured: 3 months
Oral glucose tolerance test
A venous blood sample will be collected from each participant before and after the end of study. The 2-hour plasma glucose level <140 mg/DL (7.8 MMOL/L) is considered normal. A blood glucose level between 140 and 199 mg/DL (7.8 and 11 MMOL/L) is considered impaired glucose tolerance, or pre-diabetes.
Measured: 3 months
Fasting plasma insulin
A venous blood sample will be collected from each participant before and after the end of study. Fasting plasma insulin level will be measured for all participants in both groups (A\&B) after at least 8 hours of fasting. Normal insulin level is 3-8µIU/ml, mild insulin resistance is 8-10µIU/ml, moderate insulin resistance is 10-12µIU/ml and sever insulin resistance is >12 µIU/ml.
Measured: 3 months
Glucose /insulin ratio
A venous blood sample will be collected from each participant before and after the end of study. A G/I ratio of less than 4.5 has been shown to be sensitive and specific for insulin resistance in a group of women with PCOS.
Measured: 3 months
Homeostasis Model Assessment (HOMA IR)
It will be calculated for all participants in both groups (A\&B) before and after the end of the treatment according to the following equation: HOMA-IR = insulin (MU/L) × glucose (mmol/L)/22.5. HOMA-IR ≥2.5 should be considered a reasonable indicator of insulin resistance.
Measured: 3 months
Secondary outcomes (1)
Polycystic Ovary Syndrome Quality of Life scale (PCOSQ)
The quality of life of participants in both groups (A \& B) will be assessed before and after the treatment program using a 26-item questionnaire divided into five sections: emotions (8 items), body hair (5 items), weight concerns (5 items), infertility concerns (4 items), and menstrual irregularities (4 items). Each item is rated on a seven-point scale, where 7 indicates the best situation and 1 the worst. Scores are calculated as means for each domain, with total scores categorized into four intervals reflecting varying effects on quality of life.Ultimately, the first interval values (from 1 to < 3 points) represent marked effects on quality of life; second interval values (from 3 to < 4 points) represent the marginal effect on quality of life; third interval values (from 4 to < 5 points) represent the minimal effect on quality of life; fourth interval (5 points) represents no effect on quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start20 Aug 2024 (estimated)
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena Faiez Shenouda, Cairo University
- Investigators
- Azza Barmoud Nashed Kassab, PhD, Study chair, Professor of Physical Therapy for Woman's Health, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549647
- Sponsor's protocol ID
- P.T.REC/012/005182
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2024
- 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture on Insulin Resistance in Obese Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT06549647
- Acronym / sponsor ID
- P.T.REC/012/005182
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 12 Aug 2024 (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.
This study will be conducted to investigate the effect of laser acupuncture on insulin resistance in obese women with polycystic ovarian syndrome.
Detailed description
Women with Polycystic Ovary Syndrome (PCOS) face an increased risk of various health issues, including glucose intolerance, type 2 diabetes, hypertension, dyslipidemia, and subfertility. The prevalence of insulin resistance (IR) in PCOS can range from 44% to 70%, with longitudinal studies indicating that worsening IR over time in obese women with PCOS is associated with an increased risk of early-onset type 2 diabetes.
Conventional interventions, such as oral contraceptives, metformin, and hormonal therapy, have been developed to address the effects of PCOS. However, these treatments can have adverse side effects, including an increased risk of estrogen-related cancers. Consequently, lifestyle modifications to prevent aberrant immune activation and minimize exposure to inflammatory agents have emerged as a more sustainable approach.
Emerging evidence suggests the potential of alternative physical therapy modalities, such as transcutaneous electrical nerve stimulation, electro-acupuncture, and laser acupuncture, in managing PCOS. Laser acupuncture, in particular, has been shown to reduce sympathetic activity, decrease ovarian androgen release, and modulate the activity of higher centers, ultimately influencing gonadotropin-releasing hormone secretion and the menstrual cycle. Additionally, laser acupuncture may reduce the levels of pro-inflammatory cytokines, which contribute to insulin resistance and atherosclerosis.
While a few studies have investigated the effects of laser acupuncture on insulin resistance in obese women with PCOS, further research is needed to provide deeper insights into the benefits of this intervention and its role in managing insulin resistance in this population, which could expand the clinical applications of laser therapy in physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo laser on acpoints + low caloric diet | Placebo comparator | Other: low caloric diet, Other: Placebo laser acupoint stimulationIt will be consisted of 20 obese women diagnosed as having PCOS. Each will receive placebo laser on acupoints (3 sessions/week, 17 minutes/ session) in addition to low caloric diet for 3 months. |
| Laser acupuncture + low caloric diet | Experimental | Other: low caloric diet, Other: Laser AcupunctureIt will be consisted of 20 obese women diagnosed as having PCOS who will receive the same low caloric diet as in group (A) in addition to application of laser acupuncture on (REN 4,5), (ST 25,29,36,40), (CV 3,6,10,12),(SP 6), (L14), 1 minutes for each points (17 minutes/session), 3 times/week for 3 months. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Forty obese women with PCOS as clinically diagnosed by gynecologist.
- Their ages will be ranged from 20 to 35 years old.
- Their BMI will be ranged from 30-40 kg/m2
- Their waist/hip ratio will be >0.8
- All of them should have at least two criteria of the Rotterdam diagnostic criteria of PCOS.
Key exclusion criteria (4 listed)
- Cushing syndrome, diabetes mellitus, Thyroid dysfunction, Hypothalamic amenorrhea, Ovarian hyperplasia
- Respiratory, renal and liver dysfunction.
- Skin diseases and any other condition that may prevent the usage of laser (skin cancer, active acne and skin infections).
- Malignancy
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 |
|---|---|---|
| low caloric dietA low caloric diet of 1200 Kcal will be followed by participant for 3 months. The dietary intervention follows a macronutrient ratio of 15% protein, 30% fat, and 55% carbohydrates. Participants are advised to consume 170-240g of complex carbohydrates, 60-100g of fat, and 55-93g of protein per day, with 20-35g of fiber. Patients are also advised to limit salt, tea, and caffeine intake, and receive supplemental vitamins to prevent deficiencies. | Other | Laser acupuncture + low caloric diet, Placebo laser on acpoints + low caloric diet |
| Placebo laser acupoint stimulationPlacebo laser acupoint stimulation will be used for all participants in group (A). | Other | Placebo laser on acpoints + low caloric diet |
| Laser AcupunctureEazyone EZ1 level laser will be used for the treatment procedures for all participants in group (B) only. Every participant in group (B) will be instructed briefly about the effect of laser acupoints therapy to gain her confidence and co-operation. It will be applied with infrared laser with 830 nm wavelength, 5 W power output and 0.5 J energy on the following acupoints while the patient lie in supine lying position. The head of the machine will be applied perpendicularly on each point for 1 min (17 min total), 3 times/ week for 4 weeks. | Other | Laser acupuncture + low caloric diet |
Primary outcome
Body mass index (BMI)
Time frame: 3 months
It will be calculated from the weight and height of each participant in both groups (A\&B), before beginning of the study and after end of the study program, according to the following equation: BMI =(Weight (kg))/(Height square (m²)) kg/m²
Waist/hip ratio
Time frame: 3 months
It will be calculated from the waist and hip circumferences for all participants in both groups (A\&B) according to the equation waist/hip ratio= (waist / hip) before and after the end of study.
Oral glucose tolerance test
Time frame: 3 months
A venous blood sample will be collected from each participant before and after the end of study. The 2-hour plasma glucose level <140 mg/DL (7.8 MMOL/L) is considered normal. A blood glucose level between 140 and 199 mg/DL (7.8 and 11 MMOL/L) is considered impaired glucose tolerance, or pre-diabetes.
Fasting plasma insulin
Time frame: 3 months
A venous blood sample will be collected from each participant before and after the end of study. Fasting plasma insulin level will be measured for all participants in both groups (A\&B) after at least 8 hours of fasting. Normal insulin level is 3-8µIU/ml, mild insulin resistance is 8-10µIU/ml, moderate insulin resistance is 10-12µIU/ml and sever insulin resistance is >12 µIU/ml.
Glucose /insulin ratio
Time frame: 3 months
A venous blood sample will be collected from each participant before and after the end of study. A G/I ratio of less than 4.5 has been shown to be sensitive and specific for insulin resistance in a group of women with PCOS.
Homeostasis Model Assessment (HOMA IR)
Time frame: 3 months
It will be calculated for all participants in both groups (A\&B) before and after the end of the treatment according to the following equation: HOMA-IR = insulin (MU/L) × glucose (mmol/L)/22.5. HOMA-IR ≥2.5 should be considered a reasonable indicator of insulin resistance.
1 secondary outcome
Polycystic Ovary Syndrome Quality of Life scale (PCOSQ)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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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.
Manal Ahmed El-Shafei, PhD contact
Azza Barmoud Nashed Kassab, PhD study chair
Professor of Physical Therapy for Woman's Health, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing low caloric diet and Laser Acupuncture in people with Polycystic Ovary Syndrome, run by Cairo University.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mena Faiez Shenouda, B.Sc (01227003135, menafaiez18@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI) (time frame: 3 months). The study lists 6 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 12 Aug 2024.