The Impact of Laser Acupuncture on Type 2 Diabetes

NCT07661160 | Completed

• 1 other identifier: P.T.REC/012/005998
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  3 Months (Measured at baseline and after 12 weeks of treatment)

Secondary Outcomes (6)

• Waist Circumstance:

  3 Months (Measured at baseline and after 12 weeks of treatment)

• Body weight:

  3 Months (Measured at baseline and after 12 weeks of treatment)

• Height Measurement:

  3 Months (Measured at baseline and after 12 weeks of treatment)

• BMI Calculation:

  3 Months (Measured at baseline and after 12 weeks of treatment)

• Sleep Quality

  3 Months (Measured at baseline and after 12 weeks of treatment)

Study Arms (2)

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.

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.

Device: Sham Laser Acupuncture

Interventions

Laser Acupuncture DEVICE

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.

LA

Sham Laser Acupuncture DEVICE

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.

Sham LA

Eligibility Criteria

• Age: 40 Years - 50 Years
• Gender Eligibility Details: Only women are eligible to participate in this research. This means that male individuals will not be included in the study. The protocol specifies a limitation to female patients with Type 2 Diabetes within a specific age and BMI range.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

The National Institute of Diabetes and Endocrinology

Cairo, Cairo Governorate, 4260010, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rana H Elbanna, Ph.D

  Cairo University

  STUDY DIRECTOR

• Heba R Mohamed, Ph.D

  The National Institute of Diabetes and Endocrinology

  STUDY DIRECTOR

• Nesreen G Elnahas, Ph.D

  Cairo University

  STUDY CHAIR

• Noha S Gaballah, B.P.T.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study is a double-blind, sham-controlled trial. The patients are blinded to whether they receive active or sham laser, and the evaluators (outcomes assessors) are also blinded to the patient's group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Researcher

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: November 28, 2025
• Primary Completion: February 28, 2026
• Study Completion: April 30, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)