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

16 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study is a randomized, double-blind, sham-controlled clinical trial designed to test the effectiveness of Laser Acupuncture (LA) as an add-on treatment for women with Type 2 Diabetes Mellitus (T2DM). The core aim is to see if LA can significantly improve the A Body Shape Index (ABSI), a crucial measure that predicts diabetes-related health risks and overall mortality.

Significance The study addresses the need for non-pharmacological, non-invasive therapies for T2DM management. A positive finding would support integrating LA into standard care to potentially reduce complication and mortality risks by improving metabolic health indicators like ABSI.

Treatment Protocol

The active laser acupuncture uses a non-invasive, painless ,wavelength of 850 nm at a power density of 200 mW.

The treatment involves applying the laser (or sham) to 9 specific acupoints, with the goal of improving insulin resistance, decreasing Body Shape Index and lowering blood glucose.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: LA
This group will receive active laser acupuncture (low-intensity laser beams )(Wavelength:850nm, power density 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, power density 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.
Comparatore fittizio: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
A Body Shape Index (ABSI)
Lasso di tempo: 3 Months (Measured at baseline and after 12 weeks of treatment)
An allometric index calculated from WC, height, and weight. It is calculated as follows: ABSI=WC/ (BMI^ (2/3) ×height^ (1/2))
3 Months (Measured at baseline and after 12 weeks of treatment)
HbA1c:
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Waist Circumstance:
Lasso di tempo: 3 Months (Measured at baseline and after 12 weeks of treatment)
Measured by using a non-elastic measuring tape to monitor the smallest circumference between the costal margin and the iliac crest
3 Months (Measured at baseline and after 12 weeks of treatment)
Body weight:
Lasso di tempo: 3 Months (Measured at baseline and after 12 weeks of treatment)
Measured by a digital weighting scale. The participant stands with minimal movement with hands by their side. Shoes and excess clothing were removed. Weight was approximated to the nearest 0.5 kg. It can be used with the Height to measure the BMI.
3 Months (Measured at baseline and after 12 weeks of treatment)
Height Measurement:
Lasso di tempo: 3 Months (Measured at baseline and after 12 weeks of treatment)
Standing height should be measured with the head, shoulder, buttocks, and heels touching the wall or back of the stadiometer. Eyes are straight ahead, shoulders relaxed, arms at the side, legs straight with knees together, and feet flat on the ground and almost together. Height, recorded in inches or centimeters.
3 Months (Measured at baseline and after 12 weeks of treatment)
BMI Calculation:
Lasso di tempo: 3 Months (Measured at baseline and after 12 weeks of treatment)
BMI is calculated as body weight in kilograms divided by the square of the height in meters (kg/m2) to be fallen into one of 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)
3 Months (Measured at baseline and after 12 weeks of treatment)
Sleep Quality
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cairo University

Investigatori

  • Direttore dello studio: Rana H Elbanna, Ph.D, Cairo University
  • Direttore dello studio: Heba R Mohamed, Ph.D, The National Institute of Diabetes and Endocrinology
  • Cattedra di studio: Nesreen G Elnahas, Ph.D, Cairo University
  • Investigatore principale: Noha S Gaballah, B.P.T., Cairo University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 novembre 2025

Completamento primario (Effettivo)

28 febbraio 2026

Completamento dello studio (Effettivo)

30 aprile 2026

Date di iscrizione allo studio

Primo inviato

16 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • P.T.REC/012/005998

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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