Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Changes in Body mass index (BMI) i
研究概览
简要总结
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.
详细描述
Record the following indicators before and after intervention, including height, weight, BMI, blooAccording to previous literature, dapagliflozin has a weight loss effect on overweight/obese individuals. This study is a prospective, open label, single arm, exploratory clinical trial, expected to include 36 overweight women. The subjects enter a 4-week introduction period, during which they need to maintain their original dietary habits and record a 24-hour dietary review on the 3rd of each week. At the end of the introduction period, if the weight change of the subject is less than 3%, it is considered qualified. Then, qualified subjects will receive a 12 week intervention with dapagliflozin tablets (oral, 10mg, once a day). During the experiment, participants were required to maintain their original dietary habits unchanged. Participants are required to record their dietary habits for three days a week in order to determine their energy intake and carbohydrate energy ratio. d pressure, waist circumference, abdominal circumference, waist to hip ratio, morning urine routine, 24-hour urine glucose, fasting blood glucose, fasting insulin, blood lipids (TG/TC/LDL/HDL), body fat percentage, body fat mass, muscle mass, subcutaneous fat, visceral fat volume, and abdominal fat volume, and record any adverse reaction events that occurred during the study. Collect patient urine and serum samples for testing. Collect patient feces, freeze the samples in a -80 ℃ freezer, and send the feces to a biological company for testing of intestinal microbiota composition.
Conduct subgroup analysis, based on the 24-hour dietary review provided by the subjects on the 3rd day of the week during the introduction period, subjects with carbohydrate energy greater than or equal to 26% of their daily energy intake will be included in the non low carbohydrate group (NCD group), and subjects with carbohydrate energy accounting for 10-25% of their daily energy intake will be included in the low carbohydrate group (LCD group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-45 years.
- •23.9kg/m2< BMI<28kg/m
- •Less than 60 minutes of light activity per week.
- •No contraindications to MRI.
- •Voluntary participation and willingness to sign informed consent.
排除标准
- •The weight change in the past three months is greater than 5%.
- •Taking any medications or dietary supplements in the past 3 months that would affect weight/energy expenditure.
- •Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure≥ 90 mmHg.
- •Including endocrine disorders such as diabetes and hyperthyroidism.
- •Patients with the presence of acute/chronic infections, heart, liver, lung and kidney diseases.
- •Alcoholism, smoking, strenuous exercise in the past 3 months.
- •History of recurrent urinary tract infections.
- •History of malignancy.
- •Severe renal insufficiency, severe hepatic insufficiency.
- •Patients who are pregnant, planning to become pregnant in the near future, or breastfeeding.
- •Those with other conditions that prevent them from participating in the completion of the intervention follow-up.
- •Participation in other clinical trials within the past 4 weeks.
研究组 & 干预措施
Dapagliflozin
Dapagliflozin tablets oral 10mg/d qd. Treatment course:12 weeks. Then, subgroup analysis was conducted. According to the 24-hour dietary review on the 3rd day of each week during the introduction period, subjects with carbohydrate energy greater than or equal to 26% of their daily energy intake were included in the non low carbohydrate group (NCD group), while subjects with carbohydrate energy accounting for 10-25% of their daily energy intake were included in the low carbohydrate group (LCD group).
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Changes in Body mass index (BMI) i
时间窗: At 12th week after the intervention.
When measuring height, the subjects are required to take off their shoes, hats, and coats, keep their feet together in an upright position, keep their shoulders, head, and heels close to the ruler, and look straight ahead with the right-angle plate close to the top of the head. The measurement standard of height is accurate to 0.1cm. When measuring body weight, the subjects are required to take off their shoes, hats, and single clothes for measurement and the measurement standard of body weight is accurate to 0.1kg. Body mass index (BMI) is calculated by dividing body weight (kg) by the square of height (m2). All measurements will be performed by trained staff.
次要结局
- The incidence of adverse events.(At 12th week after the intervention.)
- Changes in urine.(At 12th week after the intervention.)
- Changes in fasting blood glucose.(At 12th week after the intervention.)
- Changes in abdominal circumference.(At 12th week after the intervention.)
- Changes in Blood triglycerides(At 12th week after the intervention.)
- Changes in total cholesterol(At 12th week after the intervention.)
- Changes in β-hydroxybutyric acid.(At 12th week after the intervention.)
- Changes in muscle mass.(At 12th week after the intervention.)
- Changes in visceral fat volume.(At 12th week after the intervention.)
- Changes in waist circumference.(At 12th week after the intervention.)
- Changes in subcutaneous fat volume.(At 12th week after the intervention.)
- Changes in the relative abundance of gut microbiota.(At 12th week after the intervention.)
- Changes in fasting insulin.(At 12th week after the intervention.)
- Changes in insulin resistance index.(At 12th week after the intervention.)
- Changes in low-density lipoprotein、high-density lipoprotein(At 12th week after the intervention.)
- Changes in body fat percentage.(At 12th week after the intervention.)
- Changes in body fat volume.(At 12th week after the intervention.)
- Changes in waist-to-hip ratio.(At 12th week after the intervention.)
- Changes in hip circumference.(At 12th week after the intervention.)
研究者
Sun Jia
Chief Physician
Zhujiang Hospital