Polycystic Ovary SyndromeNCT07806656
Acupuncture for Insulin Resistance in Women With Polycystic Ovary Syndrome
A study testing Active Acupuncture and Lifestyle Management in people with Polycystic Ovary Syndrome, run by Peking University Third Hospital at 1 site in China.
Trial summary
This two-stage clinical research programme aims to evaluate the preliminary effectiveness and safety of acupuncture for improving insulin resistance in women with polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Active Acupuncture and Lifestyle Management
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 29 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 to 40 years
- BMI ≥ 24 and <40
- PCOS diagnosis according to Rotterdam criteria 2003 [23] with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL
- Voluntarily participate in this research project and sign the informed consent form
Who cannot join
- Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia, thyroid dysfunction and hyperprolactinemia
- Type I diabetes or not well controlled type II diabetes
- Pharmacological or acupuncture treatment within past 3 months
- Pregnancy or breastfeeding in the last 6 months
- Blood pressure >160/100mmHg
- Daily smoking and alcoholic intake
- Mental problems
- Language or mental disorders, or inability to understand the experimental content
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Weiqi Zhang, Master contact
China1 site
Peking University third hospital
Beijing, Beijing Municipality, 100191
Weiqi Zhang, Master, 15010901069, zhangweiqi@bjmu.edu.cn
About this study
Official title: Effects of Acupuncture on Homeostatic Model Assessment of Insulin Resistance in Women With Polycystic Ovary Syndrome: Study Protocol for a Randomized Controlled Trial
This two-stage clinical research programme aims to evaluate the preliminary effectiveness and safety of acupuncture for improving insulin resistance in women with polycystic ovary syndrome (PCOS). Phase I will be a prospective, single-centre, open-label, single-arm exploratory trial involving 20 participants, all of whom will receive active acupuncture plus lifestyle management. Acupuncture will be administered three times per week for 12 weeks, followed by a 12-week follow-up period. The study will primarily assess safety, tolerability, feasibility, and the preliminary change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to Week 12. The effect size and variability of HOMA-IR change, together with safety, adherence, and dropout data obtained from Phase I, will be used to determine the sample size and finalize the design of Phase II. Phase II is planned as a prospective, multicentre, parallel, randomized, participant- and outcome assessor-blinded, sham-controlled trial comparing active acupuncture plus lifestyle management with sham acupuncture plus lifestyle management to confirm the effectiveness and safety of the intervention.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder among women of reproductive age. Insulin resistance is considered an important pathogenic feature of PCOS and is associated with hyperandrogenism, ovulatory dysfunction, infertility, and an increased long-term risk of type 2 diabetes and cardiovascular disease. Although acupuncture has been used for reproductive and metabolic disorders, evidence regarding its effects on insulin resistance in women with PCOS remains limited.
This clinical research programme consists of two sequential phases. Phase I is a prospective, single-centre, open-label, single-arm exploratory clinical trial. A total of 20 women with PCOS will be enrolled, and all participants will receive active acupuncture plus lifestyle management. The objectives of Phase I are to evaluate the safety, tolerability, and feasibility of the intervention and to explore its preliminary effects on insulin resistance in women with PCOS.
Participants will receive 30-minute acupuncture sessions three times per week for 12 consecutive weeks, for a maximum of 36 treatment sessions. Active acupuncture will be performed using two standardized sets of acupuncture points that will be used alternately. Needles will be inserted to an appropriate depth and manually stimulated to elicit de qi. Selected acupuncture points will receive low-frequency electrical stimulation at 2 Hz. Acupuncture points not connected to the electrical stimulator will be manually stimulated at regular intervals during each treatment session.
All participants will receive individualized lifestyle management beginning at baseline. The lifestyle programme combines nutritional consultation, dietary and physical activity guidance, a web- and mobile-based PCOS management platform, and a wearable step counter. Participants will record their dietary intake and physical activity and will receive regular feedback from the research team.
The Phase I treatment period will last 12 weeks, followed by a 12-week post-treatment follow-up period. Outcomes will be assessed at baseline, Week 12, and Week 24. Safety outcomes will include adverse events, treatment-related adverse events, serious adverse events, and treatment discontinuations. Preliminary effectiveness will be assessed primarily by the change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to Week 12. Outcomes at Week 24 will be used to explore the durability of the intervention effects.
Secondary and exploratory outcomes will include anthropometric measurements and body composition; glucose metabolism and insulin resistance parameters; reproductive endocrine parameters; lipid profiles; menstrual frequency; ovarian morphology and ovulation status; health-related quality of life; anxiety and depression symptoms; traditional Chinese medicine constitution characteristics; treatment adherence; and participant retention. Adverse events will be monitored throughout the treatment and follow-up periods.
The magnitude and variability of the change in HOMA-IR, together with the safety, feasibility, recruitment, adherence, and dropout findings obtained from Phase I, will be used to determine whether the clinical research programme should proceed to Phase II. These Phase I data will also be used to calculate the required sample size and finalize the detailed design of the Phase II trial. Therefore, the Phase II sample size has not yet been fixed and may change according to the Phase I results.
If the Phase I findings support progression, Phase II will be conducted as a prospective, multicentre, parallel, randomized, participant- and outcome assessor-blinded, sham-controlled clinical trial. Eligible participants will be randomly allocated in a 1:1 ratio to one of the following groups:
Active acupuncture plus lifestyle management.
Sham acupuncture plus lifestyle management.
Participants in both Phase II groups will receive 30-minute active or sham acupuncture sessions three times per week for 12 consecutive weeks, followed by a 12-week follow-up period. Active acupuncture will follow the standardized protocol used and evaluated in Phase I. Sham acupuncture will involve superficial needle insertion at non-acupuncture and non-meridian points without manual stimulation. Electrodes will be attached, but the electrical stimulator will be set to zero intensity.
All Phase II participants will receive the same standardized lifestyle-management programme. Outcomes are planned to be assessed at baseline, Week 12, and Week 24. The principal Phase II efficacy outcome is expected to be the between-group difference in the change in HOMA-IR from baseline to Week 12. Phase II will confirm the effectiveness and safety of active acupuncture plus lifestyle management compared with sham acupuncture plus lifestyle management. The final Phase II protocol, outcome hierarchy, statistical analysis plan, and sample size will be specified after the Phase I results have been reviewed and before Phase II recruitment begins.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Active Acupuncture, Sham Acupuncture, Lifestyle Management
- Keywords
- Insulin Resistance, Acupuncture, Lifestyle Management, HOMA-IR
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active AcupunctureProcedure or surgery
Active acupuncture is administered for 30 minutes, three times per week for 12 consecutive weeks (up to 36 sessions). Two standardized sets of acupuncture points are alternated. Sterile needles are inserted 15-40 mm and manually stimulated to elicit de qi. Selected points receive 2-Hz electroacupuncture (0.3-ms pulse width; approximately 0.1-2.0 mA at a comfortable intensity), while needles not connected to the stimulator are manually stimulated every 10 minutes.
Sham AcupunctureProcedure or surgery
Sham acupuncture is administered for 30 minutes, three times per week for 12 consecutive weeks (up to 36 sessions). Sterile 0.20 × 20 mm needles are inserted superficially (<5 mm) at non-acupuncture and non-meridian points on the shoulder and upper arm, without manual stimulation. Electrodes are attached and the stimulator is set to zero intensity to mimic active electroacupuncture.
Lifestyle ManagementBehavioural
All participants receive individualized lifestyle management beginning at baseline. The program combines face-to-face nutritional consultation with a web- and mobile-based PCOS management platform and wearable step counter. Participants receive individualized dietary and physical activity advice, daily exercise and diet prescriptions, weekly review of weight-loss goals and food diaries, and regular feedback from the research team.
| Study group | Role | What they receive |
|---|---|---|
| Sham Acupuncture Plus Lifestyle Management | Sham comparator | Participants receive sham acupuncture for 30 minutes, three times weekly for 12 weeks (up to 36 sessions). Sterile 0.20 × 20 mm needles are inserted superficially (<5 mm) at non-acupuncture and non-meridian points on the shoulder and upper arm, without manual stimulation. Electrodes are attached and the stimulator is set to zero intensity. Participants also receive individualized web- and mobile-assisted lifestyle management, including dietary and physical activity guidance and use of a wearable step counter. Receives: Procedure: Sham Acupuncture; Behavioral: Lifestyle Management |
| Active Acupuncture Plus Lifestyle Management | Experimental | Participants receive active acupuncture for 30 minutes, three times weekly for 12 weeks (up to 36 sessions), using alternating standardized sets of acupuncture points. Needles are inserted 15-40 mm and manually stimulated to elicit de qi. Selected points receive 2-Hz electroacupuncture at a comfortable intensity of 0.1-2.0 mA; other needles are manually stimulated every 10 minutes. Participants also receive individualized web- and mobile-assisted lifestyle management, including dietary and physical activity guidance and use of a wearable step counter. Receives: Procedure: Active Acupuncture; Behavioral: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is calculated from fasting glucose and fasting insulin concentrations. The primary endpoint is the change in HOMA-IR from baseline to the end of the 12-week treatment period.
Measured: Baseline and Week 12 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start20 Aug 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion29 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Haidian Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806656
- Sponsor's protocol ID
- PKUTHTCM
- Other IDs
- 2026-105, 82574793, 2024-01-17
- Status last verified
- Jun 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acupuncture on Homeostatic Model Assessment of Insulin Resistance in Women With Polycystic Ovary Syndrome: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07806656
- Acronym / sponsor ID
- PKUTHTCM
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Insulin Resistance, Acupuncture, Lifestyle Management, HOMA-IR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Haidian Hospital
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 29 Dec 2029 (estimated)
- First posted
- 8 Sep 2026 (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.
This two-stage clinical research programme aims to evaluate the preliminary effectiveness and safety of acupuncture for improving insulin resistance in women with polycystic ovary syndrome (PCOS). Phase I will be a prospective, single-centre, open-label, single-arm exploratory trial involving 20 participants, all of whom will receive active acupuncture plus lifestyle management. Acupuncture will be administered three times per week for 12 weeks, followed by a 12-week follow-up period. The study will primarily assess safety, tolerability, feasibility, and the preliminary change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to Week 12. The effect size and variability of HOMA-IR change, together with safety, adherence, and dropout data obtained from Phase I, will be used to determine the sample size and finalize the design of Phase II. Phase II is planned as a prospective, multicentre, parallel, randomized, participant- and outcome assessor-blinded, sham-controlled trial comparing active acupuncture plus lifestyle management with sham acupuncture plus lifestyle management to confirm the effectiveness and safety of the intervention.
Detailed description
Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder among women of reproductive age. Insulin resistance is considered an important pathogenic feature of PCOS and is associated with hyperandrogenism, ovulatory dysfunction, infertility, and an increased long-term risk of type 2 diabetes and cardiovascular disease. Although acupuncture has been used for reproductive and metabolic disorders, evidence regarding its effects on insulin resistance in women with PCOS remains limited.
This clinical research programme consists of two sequential phases. Phase I is a prospective, single-centre, open-label, single-arm exploratory clinical trial. A total of 20 women with PCOS will be enrolled, and all participants will receive active acupuncture plus lifestyle management. The objectives of Phase I are to evaluate the safety, tolerability, and feasibility of the intervention and to explore its preliminary effects on insulin resistance in women with PCOS.
Participants will receive 30-minute acupuncture sessions three times per week for 12 consecutive weeks, for a maximum of 36 treatment sessions. Active acupuncture will be performed using two standardized sets of acupuncture points that will be used alternately. Needles will be inserted to an appropriate depth and manually stimulated to elicit de qi. Selected acupuncture points will receive low-frequency electrical stimulation at 2 Hz. Acupuncture points not connected to the electrical stimulator will be manually stimulated at regular intervals during each treatment session.
All participants will receive individualized lifestyle management beginning at baseline. The lifestyle programme combines nutritional consultation, dietary and physical activity guidance, a web- and mobile-based PCOS management platform, and a wearable step counter. Participants will record their dietary intake and physical activity and will receive regular feedback from the research team.
The Phase I treatment period will last 12 weeks, followed by a 12-week post-treatment follow-up period. Outcomes will be assessed at baseline, Week 12, and Week 24. Safety outcomes will include adverse events, treatment-related adverse events, serious adverse events, and treatment discontinuations. Preliminary effectiveness will be assessed primarily by the change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to Week 12. Outcomes at Week 24 will be used to explore the durability of the intervention effects.
Secondary and exploratory outcomes will include anthropometric measurements and body composition; glucose metabolism and insulin resistance parameters; reproductive endocrine parameters; lipid profiles; menstrual frequency; ovarian morphology and ovulation status; health-related quality of life; anxiety and depression symptoms; traditional Chinese medicine constitution characteristics; treatment adherence; and participant retention. Adverse events will be monitored throughout the treatment and follow-up periods.
The magnitude and variability of the change in HOMA-IR, together with the safety, feasibility, recruitment, adherence, and dropout findings obtained from Phase I, will be used to determine whether the clinical research programme should proceed to Phase II. These Phase I data will also be used to calculate the required sample size and finalize the detailed design of the Phase II trial. Therefore, the Phase II sample size has not yet been fixed and may change according to the Phase I results.
If the Phase I findings support progression, Phase II will be conducted as a prospective, multicentre, parallel, randomized, participant- and outcome assessor-blinded, sham-controlled clinical trial. Eligible participants will be randomly allocated in a 1:1 ratio to one of the following groups:
Active acupuncture plus lifestyle management.
Sham acupuncture plus lifestyle management.
Participants in both Phase II groups will receive 30-minute active or sham acupuncture sessions three times per week for 12 consecutive weeks, followed by a 12-week follow-up period. Active acupuncture will follow the standardized protocol used and evaluated in Phase I. Sham acupuncture will involve superficial needle insertion at non-acupuncture and non-meridian points without manual stimulation. Electrodes will be attached, but the electrical stimulator will be set to zero intensity.
All Phase II participants will receive the same standardized lifestyle-management programme. Outcomes are planned to be assessed at baseline, Week 12, and Week 24. The principal Phase II efficacy outcome is expected to be the between-group difference in the change in HOMA-IR from baseline to Week 12. Phase II will confirm the effectiveness and safety of active acupuncture plus lifestyle management compared with sham acupuncture plus lifestyle management. The final Phase II protocol, outcome hierarchy, statistical analysis plan, and sample size will be specified after the Phase I results have been reviewed and before Phase II recruitment begins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Acupuncture Plus Lifestyle Management | Sham comparator | Procedure: Sham Acupuncture, Behavioral: Lifestyle ManagementParticipants receive sham acupuncture for 30 minutes, three times weekly for 12 weeks (up to 36 sessions). Sterile 0.20 × 20 mm needles are inserted superficially (<5 mm) at non-acupuncture and non-meridian points on the shoulder and upper arm, without manual stimulation. Electrodes are attached and the stimulator is set to zero intensity. Participants also receive individualized web- and mobile-assisted lifestyle management, including dietary and physical activity guidance and use of a wearable step counter. |
| Active Acupuncture Plus Lifestyle Management | Experimental | Procedure: Active Acupuncture, Behavioral: Lifestyle ManagementParticipants receive active acupuncture for 30 minutes, three times weekly for 12 weeks (up to 36 sessions), using alternating standardized sets of acupuncture points. Needles are inserted 15-40 mm and manually stimulated to elicit de qi. Selected points receive 2-Hz electroacupuncture at a comfortable intensity of 0.1-2.0 mA; other needles are manually stimulated every 10 minutes. Participants also receive individualized web- and mobile-assisted lifestyle management, including dietary and physical activity guidance and use of a wearable step counter. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20 to 40 years
- BMI ≥ 24 and <40
- PCOS diagnosis according to Rotterdam criteria 2003 [23] with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL
- Voluntarily participate in this research project and sign the informed consent form
Key exclusion criteria (8 listed)
- Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia, thyroid dysfunction and hyperprolactinemia
- Type I diabetes or not well controlled type II diabetes
- Pharmacological or acupuncture treatment within past 3 months
- Pregnancy or breastfeeding in the last 6 months
- Blood pressure >160/100mmHg
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 |
|---|---|---|
| Active AcupunctureActive acupuncture is administered for 30 minutes, three times per week for 12 consecutive weeks (up to 36 sessions). Two standardized sets of acupuncture points are alternated. Sterile needles are inserted 15-40 mm and manually stimulated to elicit de qi. Selected points receive 2-Hz electroacupuncture (0.3-ms pulse width; approximately 0.1-2.0 mA at a comfortable intensity), while needles not connected to the stimulator are manually stimulated every 10 minutes. | Procedure or surgery | Active Acupuncture Plus Lifestyle Management |
| Sham AcupunctureSham acupuncture is administered for 30 minutes, three times per week for 12 consecutive weeks (up to 36 sessions). Sterile 0.20 × 20 mm needles are inserted superficially (<5 mm) at non-acupuncture and non-meridian points on the shoulder and upper arm, without manual stimulation. Electrodes are attached and the stimulator is set to zero intensity to mimic active electroacupuncture. | Procedure or surgery | Sham Acupuncture Plus Lifestyle Management |
| Lifestyle ManagementAll participants receive individualized lifestyle management beginning at baseline. The program combines face-to-face nutritional consultation with a web- and mobile-based PCOS management platform and wearable step counter. Participants receive individualized dietary and physical activity advice, daily exercise and diet prescriptions, weekly review of weight-loss goals and food diaries, and regular feedback from the research team. | Behavioural | Active Acupuncture Plus Lifestyle Management, Sham Acupuncture Plus Lifestyle Management |
Primary outcome
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline and Week 12 (end of treatment)
HOMA-IR is calculated from fasting glucose and fasting insulin concentrations. The primary endpoint is the change in HOMA-IR from baseline to the end of the 12-week treatment period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Weiqi Zhang, Master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Acupuncture and Lifestyle Management in people with Polycystic Ovary Syndrome, run by Peking University Third Hospital at 1 site 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haolin Zhang, Doctor (15611963539 Ext.86, zoe@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) (time frame: Baseline and Week 12 (end of treatment)). 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 8 Sep 2026.