NCT05347030

Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population

Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population: a Multi-center Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Yan Yan · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, parallel-group, participants- and assessors-blinded randomized trial aiming to evaluate the effectiveness and safety of acupuncture in improving glucose metabolism for overweight/obese Participants with IGT, in comparison with sham acupuncture.

Detailed description

The trial will be conducted at three hospitals in China. 196 eligible subjects will be randomly assigned (1:1) to the acupuncture or sham acupuncture group to receive either 30-session acupuncture/sham acupuncture treatment over 12 weeks based on lifestyle intervention and 24-week follow-up. The primary outcome is the change in the value of 2-hour blood glucose (2hPG) from baseline at the end of the 12-week treatment. Additionally, compliance, blinding, and safety will also be assessed. All statistical tests will be performed using a two-sided test, a p-value of less than 0.05 is considered significant.

Conditions

• Impaired Glucose Tolerance
• Overweight
• Obese
• Prediabetic State

Interventions

Type	Name	Description
OTHER	Acupuncture	During the 12-week treatment, acupuncture will be administrated 3 times a week (once every other day) in the first 6 weeks, and twice a week in the last 6 weeks (with an interval of 2-3 days). Each treatment session will last 30 minutes.
OTHER	Sham Acupuncture	During the 12-week treatment, Sham Acupuncture will be administrated 3 times a week (once every other day) in the first 6 weeks, and twice a week in the last 6 weeks (with an interval of 2-3 days). Each treatment session will last 30 minutes.

Timeline

• Start date: 2022-10-06
• Primary completion: 2024-07-01
• Completion: 2024-12-31
• First posted: 2022-04-26
• Last updated: 2023-02-23

Locations

1 site across 1 country: China