Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

16. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Sham-komparator: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
A Body Shape Index (ABSI)
Tidsramme: 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:
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Waist Circumstance:
Tidsramme: 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:
Tidsramme: 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:
Tidsramme: 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:
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Efterforskere

  • Studieleder: Rana H Elbanna, Ph.D, Cairo University
  • Studieleder: Heba R Mohamed, Ph.D, The National Institute of Diabetes and Endocrinology
  • Studiestol: Nesreen G Elnahas, Ph.D, Cairo University
  • Ledende efterforsker: Noha S Gaballah, B.P.T., Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. november 2025

Primær færdiggørelse (Faktiske)

28. februar 2026

Studieafslutning (Faktiske)

30. april 2026

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P.T.REC/012/005998

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 2 diabetes

Kliniske forsøg med Laser Acupuncture

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Africa

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner