protocolSection identificationModule nctId: NCT06383832, orgStudyIdInfo id: 20240310_GY, briefTitle: Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-28, primaryCompletionDateStruct date: 2023-12-26, completionDateStruct date: 2023-12-26, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Sun Jia, class: OTHER, descriptionModule briefSummary: In recent years, the prevalence of overweight and obesity has increased dramatically worldwide, of which 34.3% and 16.4% of adults in China are overweight and obese, respectively, ranking first in the world's obese population. Dapagliflozin is a sodium-glucose transporter 2 Inhibitors that inhibits glucose reabsorption and promotes urinary glucose excretion by inhibiting renal proximal tubular sodium-glucose transporter 2 Inhibitors for the treatment of type 2 diabetes mellitus. The urinary glucose excretion induced by dapagliflozin can induce weight loss through energy loss or body water loss caused by osmotic diuresis. In addition, in patients with type 2 diabetes, dapagliflozin may also induce weight loss by reducing body fat as well as subcutaneous and visceral fat.In a randomized controlled trial, type 2 diabetes patients treated with sodium-glucose transporter 2 Inhibitors lost approximately 1-3 kg. Also, sodium-glucose transporter 2 Inhibitors have shown good weight loss in obese people without type 2 diabetes. In real-world studies, a minority of type 2 diabetes patients taking dapagliflozin experienced weight gain. The American Lipid Association defines a low carbohydrate diet as the calorie intake of carbohydrates accounting for 10-25% of the total daily energy intake. In a randomized controlled trial, a low-carbon diet showed a more significant decrease in body weight, fat mass index, whole body fat, and visceral fat after 8 weeks compared to the standard diet. So, this study intends to investigate whether the weight loss effect of dapagliflozin is affected by different dietary structures., conditionsModule conditions: Overweight, conditions: Carbohydrate, conditions: Sodium-glucose Transporter 2 Inhibitors, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study included a total sample size of 36 subjects and underwent a 12 week intervention with dapagliflozin. Then, subgroup analysis was conducted. According to the 24-hour dietary review method on the 3rd day of each week during the introduction period, the low carbohydrate group accounted for 10-25% of the total energy intake due to carbohydrates, while the non low carbohydrate group accounted for 26% or more of the total energy intake due to carbohydrates., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Dapagliflozin, outcomesModule primaryOutcomes measure: Changes in Body mass index (BMI) i, secondaryOutcomes measure: Changes in fasting blood glucose., secondaryOutcomes measure: Changes in waist circumference., secondaryOutcomes measure: Changes in insulin resistance index., secondaryOutcomes measure: Changes in waist-to-hip ratio., secondaryOutcomes measure: Changes in abdominal circumference., secondaryOutcomes measure: Changes in Blood triglycerides, secondaryOutcomes measure: Changes in total cholesterol, secondaryOutcomes measure: Changes in low-density lipoprotein、high-density lipoprotein, secondaryOutcomes measure: Changes in body fat percentage., secondaryOutcomes measure: Changes in subcutaneous fat volume., secondaryOutcomes measure: Changes in body fat volume., secondaryOutcomes measure: Changes in the relative abundance of gut microbiota., secondaryOutcomes measure: Changes in urine., secondaryOutcomes measure: Changes in β-hydroxybutyric acid., secondaryOutcomes measure: Changes in muscle mass., secondaryOutcomes measure: Changes in fasting insulin., secondaryOutcomes measure: Changes in visceral fat volume., secondaryOutcomes measure: Changes in hip circumference., secondaryOutcomes measure: The incidence of adverse events., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhujiang Hospital of Southern Medical University, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Zhujiang Hospital, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False