Acupoint Catgut Embedding With Laser Acupuncture for Weight Loss in Adults With Obesity

ConditionsObesity Obesity, Abdominal Overweight

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-65

SponsorTaipei City Hospital

About this trial

Acupoint catgut embedding and laser acupuncture have each been studied as treatments for obesity in adults, but the two have not been evaluated in combination, and few trials have measured anthropometric, biochemical, and blood pressure outcomes together.

This single-center randomized sham-controlled trial plans to enroll 120 adults aged 20 to 65 years with obesity. All participants receive the same acupoint catgut embedding with poliglecaprone 25 absorbable suture at 15 acupoints, comprising 25 insertions, once every 2 weeks for 6 sessions over 12 weeks. Participants are randomly assigned in a 1:1 ratio to receive, immediately before each embedding session, either active 810 nm laser acupuncture or sham laser acupuncture delivered with a device that is identical in appearance, indicator light, and operating sound but emits no therapeutic energy. Both groups also receive standardized dietary and exercise counseling.

Because the acupoint embedding regimen is identical in both groups and the groups differ only in whether the laser emits energy, the comparison estimates the incremental effect of laser acupuncture added to acupoint embedding. Participants are treated for 12 weeks and then followed for a further 12 weeks, to Week 24.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20 to 65 years

Body mass index of 27 kg/m² or greater, or body mass index of 24 kg/m² or greater together with a waist circumference of 90 cm or greater in men or 80 cm or greater in women

Able to fully understand the informed consent document and willing to give written informed consent

No use of weight-loss medication and no other weight-reduction treatment in the 3 months before enrollment

Disqualifiers

Current use of medication that may affect body weight, including corticosteroids, antipsychotics, insulin, or glucagon-like peptide-1 (GLP-1) receptor agonists

Known secondary cause of obesity, such as hypothyroidism, Cushing syndrome, or pituitary disease

Severe cardiovascular, hepatic, or renal disease, or poorly controlled diabetes defined as glycated hemoglobin (HbA1c) above 9 percent

Currently pregnant, breastfeeding, or planning pregnancy within 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

Acupoint catgut embedding
Procedure/Surgery
Poliglecaprone 25 absorbable suture, in segments of approximately 1 to 1.5 cm, is implanted subcutaneously at acupoints with a disposable 22-gauge or 24-gauge embedding needle. Fifteen acupoints are treated at each session, giving 25 insertions in total: ST25, CV12, ST24, ST21, CV10, CV9, SP15, CV6, CV4, ST28, ST27, and GB26 on the abdomen, and ST40, ST36, and SP9 on the limbs, with bilateral points treated on both sides. Sessions occur once every 2 weeks at Weeks 0, 2, 4, 6, 8, and 10.
Active laser acupuncture
Device
An RJ Laser Pen with a gallium aluminium arsenide semiconductor laser diode, wavelength 810 nm, maximum output 500 milliwatts, continuous wave, is applied with a contact probe. Irradiation is delivered to the same acupoint sites that receive embedding, for 10 seconds per site, delivering 5 joules per site at approximately 20 joules per square centimeter, immediately before the acupoint embedding at each of the 6 sessions. Safety goggles are worn during irradiation.
Sham laser acupuncture
Device
A dedicated sham laser pen supplied by the manufacturer is applied to the same acupoints, for the same duration, and on the same schedule as the active laser. The sham pen is identical to the active pen in housing, red indicator light, and operating sound, but its laser module is disconnected so that actual output is 0 milliwatts.
Dietary and exercise counseling
Behavioral
Standardized dietary counseling is given at baseline and at Week 6, advising a daily energy intake approximately 500 kilocalories below requirement without a prescribed menu, together with a recommendation of at least 150 minutes per week of moderate-intensity aerobic exercise. Participants complete a weekly diet and exercise log.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Acupoint catgut embedding plus active laser acupunctureExperimental treatment 3 interventions

Group B: Acupoint catgut embedding plus sham laser acupunctureSham comparator 3 interventions

Trial outcomes

Primary outcomes

Mean Change From Baseline in Body Weight at Week 12

Body weight in kilograms, measured on a calibrated scale by a trained assessor.

Time frame

Baseline and Week 12

Secondary outcomes

Mean Change From Baseline in Body Weight at Weeks 18 and 24

Body weight in kilograms during the follow-up period after the end of the 12-week intervention, measured on a calibrated scale by a trained assessor.

Time frame

Baseline, Week 18, and Week 24

Mean Change From Baseline in Body Mass Index

Body mass index in kg/m\^2, calculated from measured height and weight.

Time frame

Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24

Mean Change From Baseline in Waist Circumference

Waist circumference in centimeters, measured by a trained assessor.

Time frame

Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24

Mean Change From Baseline in Hip Circumference

Hip circumference in centimeters, measured by a trained assessor.

Time frame

Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24

Other outcomes

James Blinding Index

Participants are asked at Week 12 to guess which group they were assigned to. The James blinding index is calculated from these guesses and ranges from 0 to 1, where higher values indicate that participants were less able to identify their assignment.

Time frame

Week 12

Bang Blinding Index

Participants are asked at Week 12 to guess which group they were assigned to. The Bang blinding index is calculated separately for each group and ranges from -1 to 1, where values closer to 0 indicate that participants were less able to identify their assignment.

Time frame

Week 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei City Hospital

Lead sponsor

Taipei City Government Department of Health

Collaborator

Source ClinicalTrials.gov

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