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

7 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

50

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Falso: 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.
Dispositivo: 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.
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
HbA1c:
Prazo: 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)
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sleep Quality
Prazo: 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
Prazo: 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:
Prazo: 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:
Prazo: 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:
Prazo: 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:
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Cairo University

Investigadores

  • Diretor de estudo: Rana H Elbanna, Ph.D, Cairo University
  • Diretor de estudo: Heba R Mohamed, Ph.D, The National Institute of Diabetes and Endocrinology
  • Cadeira de estudo: Nesreen G Elnahas, Ph.D, Cairo University
  • Investigador principal: Noha S Gaballah, B.P.T., Cairo University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

28 de novembro de 2025

Conclusão Primária (Real)

28 de fevereiro de 2026

Conclusão do estudo (Real)

30 de abril de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

16 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

22 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • P.T.REC/012/005998

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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