The Impact of Laser Acupuncture on Type 2 Diabetes (LA/ABSI)

July 7, 2026 updated by: Noha Salem Mohamed Gaballah, Cairo University

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:

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 4260010
        • The National Institute of Diabetes and Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham LA

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.
Device: Sham Laser Acupuncture
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.
Experimental: LA
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.
Device: Laser Acupuncture

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 Months (Measured at baseline and after 12 weeks of treatment)
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)
3 Months (Measured at baseline and after 12 weeks of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: 3 Months (Measured at baseline and after 12 weeks of treatment)

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).
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)
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)
3 Months (Measured at baseline and after 12 weeks of treatment)
Waist Circumstance:
Time Frame: 3 Months (Measured at baseline and after 12 weeks of treatment)
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.
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)
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.
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)
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.
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)
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
3 Months (Measured at baseline and after 12 weeks of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Rana H Elbanna, Ph.D, Cairo University
  • Study Director: Heba R Mohamed, Ph.D, The National Institute of Diabetes and Endocrinology
  • Study Chair: Nesreen G Elnahas, Ph.D, Cairo University
  • Principal Investigator: Noha S Gaballah, B.P.T., Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2025

Primary Completion (Actual)

February 28, 2026

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005998

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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