Clinical trial NCT06383832: Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet.
Official title: Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overweight
Carbohydrate
Sodium-glucose Transporter 2 Inhibitors
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Women.
* Age 18-45 years.
* 23.9kg/m2\< BMI\<28kg/m2.
* Less than 60 minutes of light activity per week.
* No contraindications to MRI.
* Voluntary participation and willingness to sign informed consent.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Body mass index (BMI) i
timeFrame: At 12th week after the intervention.
Secondary outcomes:
measure: Changes in fasting blood glucose.
timeFrame: At 12th week after the intervention.
measure: Changes in waist circumference.
timeFrame: At 12th week after the intervention.
measure: Changes in insulin resistance index.
timeFrame: At 12th week after the intervention.
measure: Changes in waist-to-hip ratio.
timeFrame: At 12th week after the intervention.
measure: Changes in abdominal circumference.
timeFrame: At 12th week after the intervention.
measure: Changes in Blood triglycerides
timeFrame: At 12th week after the intervention.
measure: Changes in total cholesterol
timeFrame: At 12th week after the intervention.
measure: Changes in low-density lipoprotein、high-density lipoprotein
timeFrame: At 12th week after the intervention.
measure: Changes in body fat percentage.
timeFrame: At 12th week after the intervention.
measure: Changes in subcutaneous fat volume.
timeFrame: At 12th week after the intervention.
measure: Changes in body fat volume.
timeFrame: At 12th week after the intervention.
measure: Changes in the relative abundance of gut microbiota.
timeFrame: At 12th week after the intervention.
measure: Changes in urine.
timeFrame: At 12th week after the intervention.
measure: Changes in β-hydroxybutyric acid.
timeFrame: At 12th week after the intervention.
measure: Changes in muscle mass.
timeFrame: At 12th week after the intervention.
measure: Changes in fasting insulin.
timeFrame: At 12th week after the intervention.
measure: Changes in visceral fat volume.
timeFrame: At 12th week after the intervention.
measure: Changes in hip circumference.
timeFrame: At 12th week after the intervention.
measure: The incidence of adverse events.
timeFrame: At 12th week after the intervention.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: jia sun, MD,PhD
role: STUDY_CHAIR
affiliation: Zhujiang Hospital
name: jitong li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: