Effect of Laser Acupuncture on Metabolic Syndrome in Obese Postmenopausal Women

NCT05651451 | Completed DMC

• 1 other identifier: 67
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Thirty postmenopausal women were collected from outpatient clinic of faculty of physical therapy in Benha University to participate in this study. Their ages were ranged from 55-65 years old and their body mass index (BMI) ranged from 30 to 34.9 Kg/m2. They were divided randomly into 2 equal groups; Group A: received diet regimen, Group B: received diet regimen and treated with laser acupuncture for 30 minutes, 3 sessions per week for two months

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• Lipid profile TG

  Triglycerides in mmol/L will be measured

  8 weeks after treatment

• Lipid profile HDL

  High density lipoprotein in mmol/L will be measured

  8 weeks after treatment

Study Arms (2)

Laser acupuncture group

ACTIVE COMPARATOR

All women in group (B) were received 24 activated laser acupuncture treatments. Treatments was performed 3 times per week for 8 weeks.Laser acupuncture was applied withwavelength of 810 nm, power output of 150 mW in continuous wave mode and energy density laser of 4 J/cm2 with irradiation time 3 min/point. Total duration of the training session was 30 minutes.Before starting the first treatment session, each woman was instructed briefly about the nature of the treatment to gain her confidence and cooperation. The surface of the treated skin was cleaned with alcohol wipe in order to remove any material that could absorb or disperse the radiationon the surface.The laser handheld device (laser beam spot size ≤ 36 mm2) was applied directly and perpendicularly to avoid scattering the beam, The Laser probe was applied to the surface of skin before switching on apparatus.

Device: Laser acupuncture; Dietary Supplement: energy-restricted diet

Diet regimen group

ACTIVE COMPARATOR

All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E

Dietary Supplement: energy-restricted diet

Interventions

Laser acupuncture DEVICE

24 activated laser acupuncture treatments. Treatments was performed 3 times per week for 8 weeks.Laser acupuncture was applied withwavelength of 810 nm, power output of 150 mW in continuous wave mode and energy density laser of 4 J/cm2 with irradiation time 3 min/point

Laser acupuncture group

energy-restricted diet DIETARY_SUPPLEMENT

All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E

Diet regimen group; Laser acupuncture group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• prehypertension and hypertension stage I
• overweight or obesity class I
• age 55 to 65 years

You may not qualify if:

• systolic blood pressure exceeding 159 mm Hg
• diastolic blood pressure exceeding 99 mm Hg,
• diabetic neuropathy disease,
• patients with mental or psychological disorders,
• skin disorders
• bleeding disorders
• musculoskeletal disorders

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ahmed M Maged

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 15, 2022
• Study Start: December 22, 2022
• Primary Completion: July 18, 2023
• Study Completion: September 15, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)