nctId: NCT06383832 id: 20240310_GY briefTitle: Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet. overallStatus: COMPLETED date: 2021-10-28 date: 2023-12-26 date: 2023-12-26 date: 2024-04-25 date: 2024-04-25 name: Sun Jia class: OTHER 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. conditions: Overweight conditions: Carbohydrate conditions: Sodium-glucose Transporter 2 Inhibitors studyType: INTERVENTIONAL phases: PHASE4 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 masking: NONE count: 36 type: ACTUAL name: Dapagliflozin measure: Changes in Body mass index (BMI) i measure: Changes in fasting blood glucose. measure: Changes in waist circumference. measure: Changes in insulin resistance index. measure: Changes in waist-to-hip ratio. measure: Changes in abdominal circumference. measure: Changes in Blood triglycerides measure: Changes in total cholesterol measure: Changes in low-density lipoprotein、high-density lipoprotein measure: Changes in body fat percentage. measure: Changes in subcutaneous fat volume. measure: Changes in body fat volume. measure: Changes in the relative abundance of gut microbiota. measure: Changes in urine. measure: Changes in β-hydroxybutyric acid. measure: Changes in muscle mass. measure: Changes in fasting insulin. measure: Changes in visceral fat volume. measure: Changes in hip circumference. measure: The incidence of adverse events. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Zhujiang Hospital of Southern Medical University city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False