The Impact of Laser Acupuncture on Body Shape Index in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- HbA1c:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The study is a double-blind, sham-controlled trial. The patients are blinded to whether they receive active or sham laser, and the evaluators (outcomes assessors) are also blinded to the patient's group assignment.
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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/m
- •No prior acupuncture treatment.
- •Patients that have diabetes type 2, started more than 5 year ago.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Laser Acupuncture (Device)
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.
干预措施: Sham Laser Acupuncture (Device)
结局指标
主要结局
HbA1c:
时间窗: 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.
A Body Shape Index (ABSI)
时间窗: 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)
次要结局
- Sleep Quality(3 Months (Measured at baseline and after 12 weeks of treatment))
- Diabetes Distress(3 Months (Measured at baseline and after 12 weeks of treatment))
- Waist Circumstance:(3 Months (Measured at baseline and after 12 weeks of treatment))
- Body weight:(3 Months (Measured at baseline and after 12 weeks of treatment))
- Height Measurement:(3 Months (Measured at baseline and after 12 weeks of treatment))
- BMI Calculation:(3 Months (Measured at baseline and after 12 weeks of treatment))
研究者
Noha Salem Mohamed Gaballah
Master's Researcher
Cairo University