OverweightPhase 4NCT06383832
Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet.
A Phase 4 study testing Dapagliflozin in people with Overweight and Carbohydrate, run by Sun Jia at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Overweight, Carbohydrate, Sodium-glucose Transporter 2 Inhibitors
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesChina
- Study dates
- 28 Oct 2021to 26 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Zhujiang Hospital
Guangzhou, Guangdong
About this study
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.
Read the 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).
- Being tested
- Dapagliflozin
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin tablets oral 10mg/d qd, intervention for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12th week after the intervention.
Secondary outcomes (19)
Changes in fasting blood glucose.
Fasting blood glucose will be uniformly implemented in the Laboratory.
Measured: At 12th week after the intervention.
Changes in waist circumference.
When measuring the waist circumference, the subjects were required to wear thin underwear, and the researchers used a soft ruler to measure the midpoint of the line connecting the highest point of the iliac crest and the lower edge of the 12th rib around the abdomen in the horizontal direction, and the measurement of waist circumference was accurate to 0.1cm. All measurements are performed by trained staff.
Measured: At 12th week after the intervention.
Changes in insulin resistance index.
The steady-state model assessment method will be used to calculate homeostasis model assessment of insulin resistance.
Measured: At 12th week after the intervention.
Changes in waist-to-hip ratio.
When measuring the waist circumference, the subjects were required to wear thin underwear, and the researchers used a soft ruler to measure the midpoint of the line connecting the highest point of the iliac crest and the lower edge of the 12th rib around the abdomen in the horizontal direction, and the measurement of waist circumference was accurate to 0.1cm. When measuring the hip circumference, the subjects are required to wear thin underwear, and a soft ruler is required to measure the circumference of the most protruding part backwards around the buttocks to the nearest 0.1cm. The waist-to-hip ratio is calculated by dividing the waist circumference by the hip circumference. All measurements are performed by trained staff.
Measured: At 12th week after the intervention.
Changes in abdominal circumference.
When measuring the abdominal circumference, the subjects were required to wear thin underwear and measured the circumference around the abdomen with a soft tape through the point of the iliac crest, measured to an accuracy of 0.1 cm.
Measured: At 12th week after the intervention.
Changes in Blood triglycerides
will be tested by the Laboratory.
Measured: At 12th week after the intervention.
Changes in total cholesterol
will be tested by the Laboratory.
Measured: At 12th week after the intervention.
Changes in low-density lipoprotein、high-density lipoprotein
will be tested by the Laboratory.
Measured: At 12th week after the intervention.
Changes in body fat percentage.
Body fat percentage will be tested using an body composition analyzer manufactured in Korea. Before the measurement, the subjects will be required to have an empty stomach and instructed to empty their urine and bowels. The subjects will be asked to use 75% alcohol gauze to wipe their hands and feet to make them fully contact the electrode surface of the analyzer after taking off their socks. Then researchers having training before will enter the patient's personal information on the body composition analyzer computer, and press the finish and start buttons next to get the body fat percentage measurement result.
Measured: At 12th week after the intervention.
Changes in subcutaneous fat volume.
Specialized researchers used Dutch made Philips magnetic resonance imaging to scan the abdomen and upper part of the pelvis of the subjects. The scanning was performed using body coils, and after a period of adaptation, the subjects were scanned in a fixed ambient temperature in the scanning room. Based on the open-source image processing software from Harvard Medical School in the United States, semi-automatic image segmentation is performed on fat images to obtain subcutaneous fat volume, respectively; Based on open-source image processing software in the United States, the average value represents the fat fraction of the liver.
Measured: At 12th week after the intervention.
Changes in body fat volume.
Body fat volume will be tested using an body composition analyzer manufactured in Korea. Before the measurement, the subjects will be required to have an empty stomach and instructed to empty their urine and bowels. The subjects will be asked to use 75% alcohol gauze to wipe their hands and feet to make them fully contact the electrode surface of the analyzer after taking off their socks. Then researchers having training before will enter the patient's personal information on the body composition analyzer computer, and press the finish and start buttons next to get the body fat volume measurement result.
Measured: At 12th week after the intervention.
Changes in the relative abundance of gut microbiota.
At baseline and at the end of the trial, researchers will collect fecal samples from participants, all of which will be frozen and stored in a refrigerator. After the experiment, the fecal samples will be sent to Hangzhou Lianchuan Biotechnology Co., Ltd. to extract total fecal DNA. 16S rDNA sequencing technology will be used to detect the relative abundance of intestinal microorganisms.
Measured: At 12th week after the intervention.
Changes in urine.
Morning urine routine、24h urine glucose will be uniformly implemented in the Laboratory.
Measured: At 12th week after the intervention.
Changes in β-hydroxybutyric acid.
β-hydroxybutyric acid will be implemented in the Laboratory.
Measured: At 12th week after the intervention.
Changes in muscle mass.
Muscle mass will be tested using an body composition analyzer manufactured in Korea. Before the measurement, the subjects will be required to have an empty stomach and instructed to empty their urine and bowels. The subjects will be asked to use 75% alcohol gauze to wipe their hands and feet to make them fully contact the electrode surface of the analyzer after taking off their socks. Then researchers having training before will enter the patient's personal information on the body composition analyzer computer, and press the finish and start buttons next to get the muscle mass measurement result.
Measured: At 12th week after the intervention.
Changes in fasting insulin.
Fasting blood glucose、fasting insulin will be uniformly implemented in the Laboratory.
Measured: At 12th week after the intervention.
Changes in visceral fat volume.
Specialized researchers used Dutch made Philips magnetic resonance imaging to scan the abdomen and upper part of the pelvis of the subjects. The scanning was performed using body coils, and after a period of adaptation, the subjects were scanned in a fixed ambient temperature in the scanning room. Based on the open-source image processing software from Harvard Medical School in the United States, semi-automatic image segmentation is performed on fat images to obtain visceral fat volume, respectively; Based on open-source image processing software in the United States, the average value represents the fat fraction of the liver.
Measured: At 12th week after the intervention.
Changes in hip circumference.
When measuring the hip circumference, the subjects are required to wear thin underwear, and a soft ruler is required to measure the circumference of the most protruding part backwards around the buttocks to the nearest 0.1cm. The waist-to-hip ratio is calculated by dividing the waist circumference by the hip circumference. All measurements are performed by trained staff.
Measured: At 12th week after the intervention.
The incidence of adverse events.
The investigator will ask participants in face-to-face visits or contacted with them by phone to record observed side effects and adverse events in time.
Measured: At 12th week after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start28 Oct 2021
- Primary completion26 Dec 2023
- Study completion26 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Jia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sun Jia, Zhujiang Hospital
- Investigators
- jia sun, MD,PhD, Study chair, Zhujiang Hospitaljitong li, MD,PhD, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383832
- Sponsor's protocol ID
- 20240310_GY
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet.
- ClinicalTrials.gov ID
- NCT06383832
- Acronym / sponsor ID
- 20240310_GY
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sun JiaUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 26 Dec 2023 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women.
- Age 18-45 years.
- 23.9kg/m2< BMI<28kg/m2.
- Less than 60 minutes of light activity per week.
- No contraindications to MRI.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinDapagliflozin tablets oral 10mg/d qd, intervention for 12 weeks. | Drug | Dapagliflozin |
Primary outcome
Changes in Body mass index (BMI) i
Time frame: 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.
19 secondary outcomes
Changes in fasting blood glucose.
Time frame: At 12th week after the intervention.
Changes in waist circumference.
Time frame: At 12th week after the intervention.
Changes in insulin resistance index.
Time frame: At 12th week after the intervention.
Changes in waist-to-hip ratio.
Time frame: At 12th week after the intervention.
Changes in abdominal circumference.
Time frame: At 12th week after the intervention.
Changes in Blood triglycerides
Time frame: At 12th week after the intervention.
Changes in total cholesterol
Time frame: At 12th week after the intervention.
Changes in low-density lipoprotein、high-density lipoprotein
Time frame: At 12th week after the intervention.
Changes in body fat percentage.
Time frame: At 12th week after the intervention.
Changes in subcutaneous fat volume.
Time frame: At 12th week after the intervention.
Changes in body fat volume.
Time frame: At 12th week after the intervention.
Changes in the relative abundance of gut microbiota.
Time frame: At 12th week after the intervention.
Changes in urine.
Time frame: At 12th week after the intervention.
Changes in β-hydroxybutyric acid.
Time frame: At 12th week after the intervention.
Changes in muscle mass.
Time frame: At 12th week after the intervention.
Changes in fasting insulin.
Time frame: At 12th week after the intervention.
Changes in visceral fat volume.
Time frame: At 12th week after the intervention.
Changes in hip circumference.
Time frame: At 12th week after the intervention.
The incidence of adverse events.
Time frame: At 12th week after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jia sun, MD,PhD study chair
Zhujiang Hospital
jitong li, MD,PhD principal investigator
Zhujiang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin in people with Overweight and Carbohydrate, run by Sun Jia at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Body mass index (BMI) i (time frame: At 12th week after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.