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