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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Cairo Governorate
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Cairo、Cairo Governorate、エジプト、4260010
- The National Institute of Diabetes and Endocrinology
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
偽コンパレータ：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.
|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HbA1c:
時間枠：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)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sleep Quality
時間枠：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)
|
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Diabetes Distress
時間枠：3 Months (Measured at baseline and after 12 weeks of treatment)
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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)
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3 Months (Measured at baseline and after 12 weeks of treatment)
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Waist Circumstance:
時間枠：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.
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3 Months (Measured at baseline and after 12 weeks of treatment)
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Body weight:
時間枠：3 Months (Measured at baseline and after 12 weeks of treatment)
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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.
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3 Months (Measured at baseline and after 12 weeks of treatment)
|
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Height Measurement:
時間枠：3 Months (Measured at baseline and after 12 weeks of treatment)
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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.
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3 Months (Measured at baseline and after 12 weeks of treatment)
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BMI Calculation:
時間枠：3 Months (Measured at baseline and after 12 weeks of treatment)
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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)
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Rana H Elbanna, Ph.D、Cairo University
- スタディディレクター：Heba R Mohamed, Ph.D、The National Institute of Diabetes and Endocrinology
- スタディチェア：Nesreen G Elnahas, Ph.D、Cairo University
- 主任研究者：Noha S Gaballah, B.P.T.、Cairo University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- P.T.REC/012/005998
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