The Impact of Laser Acupuncture on Type 2 Diabetes (LA/ABSI)
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 4260010
- The National Institute of Diabetes and Endocrinology
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
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. |
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.
|
|
Eksperimentell: 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.
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
|
|
A Body Shape Index (ABSI)
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
|
|
Waist Circumstance:
Tidsramme: 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:
Tidsramme: 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:
Tidsramme: 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:
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 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)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- 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
- Hovedetterforsker: Noha S Gaballah, B.P.T., Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P.T.REC/012/005998
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .