Suture Length Effects in Acupoint Implantation for Abdominal Obesity

NCT07125716 | Active Not Recruiting

• 1 other identifier: 202500161A3
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a metabolic disorder and has become a global health issue with a steadily increasing prevalence. According to the Health Promotion Administration's statistical report, the overweight and obesity rate among adults in Taiwan was 50.3% between 2017 and 2020. Based on the Ministry of Health and Welfare's criteria, a BMI ≥27 kg/m² is classified as obese. Studies have shown that acupuncture can effectively reduce body weight with low cost and minimal side effects. Acupoint catgut embedding is a treatment method that combines traditional meridian acupuncture with modern medical materials by implanting surgical sutures into acupoints to provide continuous stimulation. A 2022 systematic review found that catgut embedding is more effective than traditional acupuncture, requires fewer treatment sessions, and has a high safety profile. However, no studies have yet investigated whether different lengths of implanted surgical sutures affect treatment outcomes. This study is a single-center, double-blind, randomized controlled trial aimed at identifying the optimal suture length for acupoint catgut embedding, in order to enhance its efficiency and therapeutic effect.

Conditions

Abdominal Obesity; Obesity

Outcome Measures

Primary Outcomes (1)

• Waist circumference

  1 week,4 week,8 week

Secondary Outcomes (5)

• hip circumference

  1 week,4 week,8 week

• weight

  1 week,4 week,8 week

• BMI

  1 week,4 week,8 week

• VAS

  1 week,4 week,8 week

• Ultrasound Fat Thickness

  1 week,4 week,8 week

Study Arms (2)

1 inch suture length

EXPERIMENTAL

Device: 1 inch

0.5 inch suture length

ACTIVE COMPARATOR

Device: 0.5 inch

Interventions

1 inch DEVICE

1 inch suture length

1 inch suture length

0.5 inch DEVICE

0.5 inch suture length

0.5 inch suture length

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign a written informed consent form
• BMI ≥27 kg/m² (Ministry of Health and Welfare standard)
• Waist circumference ≥90 cm for men
• Waist circumference ≥80 cm for women
• Age between 18 and 65 years

You may not qualify if:

• Endocrine disorders (thyroid disease, pituitary disorders, and diabetes)
• Autoimmune diseases (systemic lupus erythematosus, Sjögren's syndrome, and rheumatoid arthritis)
• Heart diseases (heart failure, arrhythmia, etc.)
• Abnormal liver function
• Abnormal kidney function
• Stroke within the past year
• Pregnant or breastfeeding women
• Coagulation disorders
• Tumors
• Participation in weight loss treatment within the past 6 months
• Any other condition deemed unsuitable for the trial by the physician

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang-Geng Medical Foundation Keelung Chang-Geng Memorial Hospital

Keelung, Taiwan

Location

MeSH Terms

Conditions

Obesity, Abdominal; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 15, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-04

Locations

TW (1)