nctId: NCT06359418 id: 2024-007-KY briefTitle: Acupuncture for Obesity With Prediabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2026-12-10 date: 2027-03-30 date: 2024-04-11 date: 2024-04-11 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER name: Hubei Hospital of Traditional Chinese Medicine name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine name: Dongfang Hospital Beijing University of Chinese Medicine name: Guangdong Provincial Hospital of Traditional Chinese Medicine name: Heilongjiang Academy of traditional Chinese Medicine briefSummary: The clinical trial aims to evaluate the efficacy and safety of acupuncture on weight loss and changes of glucose and lipid metabolism in obese adults with pre-diabetes. conditions: Obesity conditions: Pre-diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 260 type: ESTIMATED name: Acupuncture name: Sham acupuncture measure: The percentage change in body weight from baseline to week 12 measure: The percentage change in body weight compared to the baseline measure: Achievement of a reduction in body weight of 5% or more compared to the baseline measure: Achievement of a reduction in body weight of 7% or more compared to the baseline measure: The change in 1hPG from baseline and percentage of patients who returned to normal measure: The change in 2hPG from baseline and percentage of patients who returned to normal measure: The change in FPG from baseline and percentage of patients who returned to normal measure: The change in HbA1c from baseline and percentage of patients who returned to normal measure: The change in waist circumference from baseline measure: The change in BMI from baseline measure: The change in WHR from baseline measure: The change in WHtR from baseline measure: The change in blood pressure from baseline measure: Changes in appetite VAS score from baseline measure: The change in FINS from baseline measure: The change in HOMA-IR from baseline measure: The change in HOMA-β from baseline measure: The change in Serum total cholesterol from baseline measure: The change in Triglyceride from baseline measure: The change in Low-Density Lipoprotein Cholesterol from baseline measure: The change in High-Density Lipoprotein Cholesterol from baseline measure: The change in Serum Uric Acid from baseline measure: Changes of the score of the European five-dimensional Health scale (EQ-5D-5L) compared with the baseline. measure: Changes of the PHQ-4 score from the baseline. measure: Expectance assessment measure: Assessment of belief in acupuncture measure: Blinding assessment measure: Safety assessment measure: Adherence assessment of acupuncture measure: Adherence assessment of life modification sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences city: Beijing country: China name: Zhishun Liu, PhD role: CONTACT phone: +861088002331 email: zhishunjournal@163.com lat: 39.9075 lon: 116.39723 hasResults: False