Completed

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

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What is being tested

Dapagliflozin

Drug
Who is being recruted

Body Weight+4

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 45 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 2021
See protocol details

Summary

Principal SponsorSun Jia
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 28, 2021

Actual date on which the first participant was enrolled.

This study is focused on understanding how a medication called dapagliflozin can help overweight women lose weight, especially when they consume different amounts of carbohydrates in their diets. Around 36 women who are overweight will participate in this trial. Initially, they will follow their usual eating habits for four weeks. If their weight doesn't change much during this period, they will continue into the next phase. The goal is to explore how effective dapagliflozin is at promoting weight loss, potentially offering a new way to manage weight, especially for those struggling with obesity. Participants will take dapagliflozin tablets by mouth once a day for 12 weeks while continuing their normal diet. To monitor progress, they will keep a detailed food diary three times a week. Researchers will collect various health indicators, including blood pressure, blood sugar levels, body measurements, and urine samples, to see how the medication affects their weight and overall health. Additionally, the study will examine the participants' gut bacteria by analyzing stool samples. Participants are divided into two groups based on their carbohydrate intake to see if the amount of carbohydrates they eat influences the effectiveness of the treatment. This study will help understand any potential side effects or benefits of using dapagliflozin for weight loss in women.

Official TitleEffect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet.
NCT06383832
Principal SponsorSun Jia
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

6 inclusion criteria required to participate
Women.

Age 18-45 years.

23.9kg/m2< BMI<28kg/m2.

Less than 60 minutes of light activity per week.

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12 exclusion criteria prevent from participating
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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Zhujiang Hospital of Southern Medical University

Guangzhou, ChinaOpen Zhujiang Hospital of Southern Medical University in Google Maps
Suspended

Zhujiang Hospital

Guangzhou, China
Completed2 Study Centers