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Completed
NCT07661160
The Impact of Laser Acupuncture on Type 2 Diabetes
Conditions: Type 2 Diabetes, ObesityType 2 Diabetes Mellitus
Sex: Female
Ages: 40 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Cairo University
Location: The National Institute of Diabetes and Endocrinology Cairo Cairo Governorate
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07661160). StuddyBuddy aggregates publicly available trial information.