Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet.

NCT06383832 | Completed Phase 4

• 1 other identifier: 20240310_GY
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight; Carbohydrate; Sodium-glucose Transporter 2 Inhibitors

Outcome Measures

Primary Outcomes (1)

• Changes in Body mass index (BMI) i

  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.

  At 12th week after the intervention.

Secondary Outcomes (19)

• Changes in fasting blood glucose.

  At 12th week after the intervention.

• Changes in waist circumference.

  At 12th week after the intervention.

• Changes in insulin resistance index.

  At 12th week after the intervention.

• Changes in waist-to-hip ratio.

  At 12th week after the intervention.

• Changes in abdominal circumference.

  At 12th week after the intervention.

Study Arms (1)

Dapagliflozin

EXPERIMENTAL

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).

Drug: Dapagliflozin

Interventions

Dapagliflozin DRUG

Dapagliflozin tablets oral 10mg/d qd, intervention for 12 weeks.

Dapagliflozin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women.
• Age 18-45 years.
• kg/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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Jia: lead

Study Sites (2)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Zhujiang Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Overweight

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• jia sun, MD,PhD

  Zhujiang Hospital

  STUDY CHAIR

• jitong li, MD,PhD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 25, 2024
• Study Start: October 28, 2021
• Primary Completion: December 26, 2023
• Study Completion: December 26, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)