Type 2 DiabetesLA/ABSINCT07661160
The Impact of Laser Acupuncture on Type 2 Diabetes
A study testing Laser Acupuncture in people with Type 2 Diabetes and ObesityType 2 Diabetes Mellitus, run by Cairo University at 1 site in Egypt.
Trial summary
Laser Acupuncture for Type 2 Diabetes and Body Shape The goal of this clinical trial is to learn if laser acupuncture can help improve body shape and overall health in women with Type 2 Diabetes (T2D). Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Type 2 Diabetes, ObesityType 2 Diabetes Mellitus
- What is being tested?
- Laser Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2025to 30 Apr 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 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients 40 -50 years.
- Patients with uncontrolled diabetes type 2 (HbA1c ≥ 7.5%)
- Clinically stable
- Sedentary active on Physical Activity Rating scale (Dicks et al., 2019).
- BMI 30-35 Kg/m2.
- No prior acupuncture treatment.
- Patients that have diabetes type 2, started more than 5 year ago.
Who cannot join
- Pregnant women.
- Positive and negative smokers
- Patients with a cardiac pacemaker
- Autoimmune diseases related to diabetes
- History of malignancy or Cancer patients.
- History of uncontrolled cardiovascular complications.
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- Photo-sensitivity or any skin conditions that may interfere with laser application.
- Participants diagnosed with pre-diabetes, gestational diabetes, or Type1 diabetes.
- Patients with severe diabetes complication
- Patients with Thyroid problems.
- Patients with severe psychological problems.
- Patients who receive anti-inflammatory steroid therapy and medications for hypercholesterolemia
- Patients with kidney or liver complications.
- Patients with chronic digestive disorders more than 3 month
- Patients who perform regular exercise.
- Patients with a history of seizures
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The National Institute of Diabetes and Endocrinology
Cairo, Cairo Governorate, 4260010
About this study
Official title: The Impact of Laser Acupuncture on Body Shape Index in Type 2 Diabetes
Laser Acupuncture for Type 2 Diabetes and Body Shape The goal of this clinical trial is to learn if laser acupuncture can help improve body shape and overall health in women with Type 2 Diabetes (T2D).
The main question it aims to answer is:
Read more
Does laser acupuncture lead to a better A Body Shape Index (ABSI) score in women with T2D compared to a sham (inactive) laser treatment?
The A Body Shape Index (ABSI) is a way to measure body shape that is linked to health risks like diabetes complications and early death. A lower ABSI score is better.
The Laser Acupuncture Group will be compared to a Sham Laser Acupuncture Group to see if the active laser treatment is more effective.
Participants will:
Be women aged 40 to 50 with uncontrolled T2D (HbA1c ≥7.5%) and a BMI between 30 and 35 (obesity class I).
Be randomly placed into one of two groups (Laser Acupuncture or Sham Laser Acupuncture).
Both groups will adhere to a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology (NIDE).
Receive treatment twice a week for 12 weeks (24 sessions total). The laser or sham laser will be applied to specific points on the body (acupoints) for 24 seconds each.
Complete evaluations before and after the 12-week program, which will include:
Measuring their ABSI (calculated using waist size, height, and weight).
Measuring their HbA1c (a blood test that shows average blood sugar over the past 3 months).
Filling out questionnaires about sleep quality and diabetes-related emotional distress.
Read the detailed description
This is a randomized, double-blind, sham-controlled clinical trial designed to test the effect of Laser Acupuncture (LA) on BSI, glycemic control, sleep quality, and diabetes-related distress in women with Type 2 Diabetes Mellitus (T2DM), combined with diet and diabetes medications.
A Body Shape Index (ABSI) is a novel anthropometric index that has shown the strongest independent association with all-cause mortality among anthropometric indices, making it a valuable non-invasive tool for early identification of high-risk individuals. It has been shown that Body Shape Index is a predictor of the risk of pathologies associated with all-cause mortality in individuals with diabetes. Therefore, monitoring ABSI and evaluating interventions that may improve it are important to decrease future health risks among patients with type 2 diabetes.
Laser acupuncture is a non-invasive, painless alternative to traditional needle acupuncture, in which low-intensity light beams stimulate acupoints to release neurotransmitters and other substances. Prior evidence suggests this stimulation may improve insulin resistance and fasting blood glucose, increasing interest in evaluating its effect on ABSI in patients with T2DM.
The study discusses complementary and non-invasive therapies for T2DM management. A positive finding support integrating laser acupuncture into standard care to potentially reduce complication and mortality risks by improving metabolic health indicators such as ABSI.
- Conditions
- Type 2 Diabetes, ObesityType 2 Diabetes Mellitus
- Being tested
- Laser Acupuncture, Sham Laser Acupuncture
- Keywords
- Laser Acupuncture, A Body Shape Index (ABSI), Obesity, Type 2 Diabetes, Anthropometry, DDS-17, PSQI, Anthropometric parameters
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser AcupunctureDevice
Application of low-intensity laser beams (Wavelength:850nm, Output power of 200 mW, Duration:24s per acupoint) to 9 specified body acupoints. Treatment frequency is 2 times/week for 12 weeks. All patients will adhere to the same Diet Plan that follow the guidelines for a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology.
Treatment frequency is 2 times/week for 12 weeks.
Sham Laser AcupunctureDevice
The same procedure as Laser Acupuncture, but the device is applied without turning it on (inactive). All patients will adhere to the same Diet Plan that follow the guidelines for a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology. Treatment frequency is 2 times/week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LA | Experimental | This group will receive active laser acupuncture (low-intensity laser beams )(Wavelength:850nm, Output power of 200 mW, Duration:24s per acupoint) to 9 specified body acupoints ( ST36, ST25, SP6, SP15, LI4, LI11, CV4, CV9 and CV12) Treatment frequency is 2 times/week for 12 weeks. All patients will adhere to the same Diet Plan that follow the guidelines for a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology. Receives: Device: Laser Acupuncture |
| Sham LA | Sham comparator | This group will receive Sham Laser Acupuncture (procedure without turning the device on) at the same specified acupoints 2 times/week for 12 weeks
All patients will adhere to the same Diet Plan that follow the guidelines for a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology. Receives: Device: Sham Laser Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Body Shape Index (ABSI)
An allometric index calculated from Waist Circumference (WC), Body Mass Index (BMI), and Height. It is calculated as follows: ABSI = WC / (BMI^(2/3) × Height^(1/2)).
ABSI does not have a fixed minimum or maximum, as it is a continuous allometric index as there is individual variations. The lower the ABSI score, the better the outcome (i.e., lower risk of morbidity and mortality)
Measured: 3 Months (Measured at baseline and after 12 weeks of treatment)
HbA1c:
It indicates the long-term glycemic control, providing an average blood glucose value over the lifespan of the red blood cell (approximately 2-3 months). It is measured by the turbidimetric inhibition immunoassay (TINIA) method.
Measured: 3 Months (Measured at baseline and after 12 weeks of treatment)
Secondary outcomes (6)
Waist Circumstance:
Measured in centimeters (cm) using a non-elastic measuring tape at the smallest circumference between the costal margin and the iliac crest, assessed after a normal expiration. There is no fixed minimum or maximum value. A lower waist circumference post-intervention indicates a better outcome.
Measured: 3 Months (Measured at baseline and after 12 weeks of treatment)
Body weight:
Measured in kilograms (kg) using a digital weighing scale, to the nearest 0.5 kg, with the participant standing with minimal movement, hands by their side, and shoes and excess clothing removed. There is no fixed minimum or maximum value. A reduction in body weight post-intervention is generally considered a favorable outcome in this population. . It can be used with Height to measure the BMI.
Measured: 3 Months (Measured at baseline and after 12 weeks of treatment)
Height Measurement:
Standing height measured in centimeters (cm) using a stadiometer, with the head, shoulders, buttocks, and heels touching the wall or back of the stadiometer, eyes straight ahead, shoulders relaxed, arms at the side, legs straight with knees together, and feet flat on the ground. This measurement is used as for calculating BMI and ABSI and is not expected to change with intervention.
Measured: 3 Months (Measured at baseline and after 12 weeks of treatment)
BMI Calculation:
BMI is calculated as body weight in kilograms divided by the square of height in meters (kg/m²), classified into the following categories: underweight (<18.5 kg/m²), normal weight (18.5-24.9 kg/m²), overweight/pre-obesity (25-29.9 kg/m²), obesity class I (30-34.9 kg/m²), obesity class II (35-39.9 kg/m²), and obesity class III (≥40 kg/m²). A lower BMI value, or a shift toward a lower category, post-intervention indicates a better outcome, reflecting improved weight status
Measured: 3 Months (Measured at baseline and after 12 weeks of treatment)
Sleep Quality
Assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire for subjective sleep quality. It is a sum of seven component scores, with each component ranging from 0 to 3.
Good Sleep Quality: A Global Score of ≤ 5 Poor Sleep Quality/Significant Sleep Disturbance: A Global Score of > 5 (Higher scores indicate worse sleep quality).
Measured: 3 Months (Measured at baseline and after 12 weeks of treatment)
Diabetes Distress
Assessed using the Diabetes Distress - Screening Scale (DDS17), a validated 17-item measure rated on a 6-point scale. 1 (not a problem) to 6 (a very significant problem) Little or No Distress: Mean item score < 2.0 Moderate Distress: Mean item score 2.0 - 2.9 (Clinically significant) High Distress: Mean item score ≥ 3.0 (Strongly warrants clinical attention)
Measured: 3 Months (Measured at baseline and after 12 weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start28 Nov 2025
- Primary completion28 Feb 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Model description
- Participants are randomly assigned to one of two groups (Laser Acupuncture or Sham Laser Acupuncture) and remain in that group for the duration of the study. Receive treatment twice a week for 12 weeks (24 sessions total). The laser or sham laser will be applied to specific points on the body (acupoints) for 24 seconds for each, adhere to the same Diet Plan that follow the guidelines for a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology and remain in the same group for the duration of the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Salem Mohamed Gaballah, Cairo University
- Investigators
- Rana H Elbanna, Ph.D, Study director, Cairo UniversityHeba R Mohamed, Ph.D, Study director, The National Institute of Diabetes and EndocrinologyNesreen G Elnahas, Ph.D, Study chair, Cairo UniversityNoha S Gaballah, B.P.T., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661160
- Sponsor's protocol ID
- P.T.REC/012/005998
- Acronym
- LA/ABSI
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Laser Acupuncture on Body Shape Index in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07661160
- Acronym / sponsor ID
- LA/ABSI / P.T.REC/012/005998
- Conditions
- Type 2 Diabetes, ObesityType 2 Diabetes Mellitus
- Keywords
- Laser Acupuncture, A Body Shape Index (ABSI), Obesity, Type 2 Diabetes, Anthropometry, DDS-17, PSQI, Anthropometric parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 22 Jun 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.
Laser Acupuncture for Type 2 Diabetes and Body Shape The goal of this clinical trial is to learn if laser acupuncture can help improve body shape and overall health in women with Type 2 Diabetes (T2D).
The main question it aims to answer is:
Does laser acupuncture lead to a better A Body Shape Index (ABSI) score in women with T2D compared to a sham (inactive) laser treatment?
The A Body Shape Index (ABSI) is a way to measure body shape that is linked to health risks like diabetes complications and early death. A lower ABSI score is better.
The Laser Acupuncture Group will be compared to a Sham Laser Acupuncture Group to see if the active laser treatment is more effective.
Participants will:
Be women aged 40 to 50 with uncontrolled T2D (HbA1c ≥7.5%) and a BMI between 30 and 35 (obesity class I).
Be randomly placed into one of two groups (Laser Acupuncture or Sham Laser Acupuncture).
Both groups will adhere to a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology (NIDE).
Receive treatment twice a week for 12 weeks (24 sessions total). The laser or sham laser will be applied to specific points on the body (acupoints) for 24 seconds each.
Complete evaluations before and after the 12-week program, which will include:
Measuring their ABSI (calculated using waist size, height, and weight).
Measuring their HbA1c (a blood test that shows average blood sugar over the past 3 months).
Filling out questionnaires about sleep quality and diabetes-related emotional distress.
Detailed description
This is a randomized, double-blind, sham-controlled clinical trial designed to test the effect of Laser Acupuncture (LA) on BSI, glycemic control, sleep quality, and diabetes-related distress in women with Type 2 Diabetes Mellitus (T2DM), combined with diet and diabetes medications.
A Body Shape Index (ABSI) is a novel anthropometric index that has shown the strongest independent association with all-cause mortality among anthropometric indices, making it a valuable non-invasive tool for early identification of high-risk individuals. It has been shown that Body Shape Index is a predictor of the risk of pathologies associated with all-cause mortality in individuals with diabetes. Therefore, monitoring ABSI and evaluating interventions that may improve it are important to decrease future health risks among patients with type 2 diabetes.
Laser acupuncture is a non-invasive, painless alternative to traditional needle acupuncture, in which low-intensity light beams stimulate acupoints to release neurotransmitters and other substances. Prior evidence suggests this stimulation may improve insulin resistance and fasting blood glucose, increasing interest in evaluating its effect on ABSI in patients with T2DM.
The study discusses complementary and non-invasive therapies for T2DM management. A positive finding support integrating laser acupuncture into standard care to potentially reduce complication and mortality risks by improving metabolic health indicators such as ABSI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two groups (Laser Acupuncture or Sham Laser Acupuncture) and remain in that group for the duration of the study. Receive treatment twice a week for 12 weeks (24 sessions total). The laser or sham laser will be applied to specific points on the body (acupoints) for 24 seconds for each, adhere to the same Diet Plan that follow the guidelines for a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology and remain in the same group for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| LA | Experimental | Device: Laser AcupunctureThis group will receive active laser acupuncture (low-intensity laser beams )(Wavelength:850nm, Output power of 200 mW, Duration:24s per acupoint) to 9 specified body acupoints ( ST36, ST25, SP6, SP15, LI4, LI11, CV4, CV9 and CV12) Treatment frequency is 2 times/week for 12 weeks. All patients will adhere to the same Diet Plan that follow the guidelines for a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology. |
| Sham LA | Sham comparator | Device: Sham Laser AcupunctureThis group will receive Sham Laser Acupuncture (procedure without turning the device on) at the same specified acupoints 2 times/week for 12 weeks All patients will adhere to the same Diet Plan that follow the guidelines for a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female patients 40 -50 years.
- Patients with uncontrolled diabetes type 2 (HbA1c ≥ 7.5%)
- Clinically stable
- Sedentary active on Physical Activity Rating scale (Dicks et al., 2019).
- BMI 30-35 Kg/m2.
Key exclusion criteria (16 listed)
- Pregnant women.
- Positive and negative smokers
- Patients with a cardiac pacemaker
- Autoimmune diseases related to diabetes
- History of malignancy or Cancer patients.
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 |
|---|---|---|
| Laser AcupunctureApplication of low-intensity laser beams (Wavelength:850nm, Output power of 200 mW, Duration:24s per acupoint) to 9 specified body acupoints. Treatment frequency is 2 times/week for 12 weeks. All patients will adhere to the same Diet Plan that follow the guidelines for a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology. Treatment frequency is 2 times/week for 12 weeks. | Device | LA |
| Sham Laser AcupunctureThe same procedure as Laser Acupuncture, but the device is applied without turning it on (inactive). All patients will adhere to the same Diet Plan that follow the guidelines for a low-glycemic-index (LGI) diet designed and prescribed by the Nutrition Clinic at the National Institute of Diabetes and Endocrinology. Treatment frequency is 2 times/week for 12 weeks. | Device | Sham LA |
Primary outcome
A Body Shape Index (ABSI)
Time frame: 3 Months (Measured at baseline and after 12 weeks of treatment)
An allometric index calculated from Waist Circumference (WC), Body Mass Index (BMI), and Height. It is calculated as follows: ABSI = WC / (BMI^(2/3) × Height^(1/2)). ABSI does not have a fixed minimum or maximum, as it is a continuous allometric index as there is individual variations. The lower the ABSI score, the better the outcome (i.e., lower risk of morbidity and mortality)
HbA1c:
Time frame: 3 Months (Measured at baseline and after 12 weeks of treatment)
It indicates the long-term glycemic control, providing an average blood glucose value over the lifespan of the red blood cell (approximately 2-3 months). It is measured by the turbidimetric inhibition immunoassay (TINIA) method.
6 secondary outcomes
Waist Circumstance:
Time frame: 3 Months (Measured at baseline and after 12 weeks of treatment)
Body weight:
Time frame: 3 Months (Measured at baseline and after 12 weeks of treatment)
Height Measurement:
Time frame: 3 Months (Measured at baseline and after 12 weeks of treatment)
BMI Calculation:
Time frame: 3 Months (Measured at baseline and after 12 weeks of treatment)
Sleep Quality
Time frame: 3 Months (Measured at baseline and after 12 weeks of treatment)
Diabetes Distress
Time frame: 3 Months (Measured at baseline and after 12 weeks of treatment)
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 9 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Rana H Elbanna, Ph.D study director
Cairo University
Heba R Mohamed, Ph.D study director
The National Institute of Diabetes and Endocrinology
Nesreen G Elnahas, Ph.D study chair
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 Laser Acupuncture in people with Type 2 Diabetes and ObesityType 2 Diabetes Mellitus, 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 7 inclusion and 16 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 9 Jul 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. 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?
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?
A Body Shape Index (ABSI) (time frame: 3 Months (Measured at baseline and after 12 weeks of treatment)). The study lists 2 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 9 Jul 2026.