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Polycystic Ovary SyndromeNCT05386706

Treating PCOS With Digital Intervention vs. Metformin

A study testing Digital Intervention and Metformin in people with Polycystic Ovary Syndrome, run by Shanghai 10th People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Digital Intervention and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
21 Jun 2022to 1 Sep 2023
Phase
Interventional
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

  • Female aged 18- 45; Meet Rotterdam criteria; Insulin Resistance

Who cannot join

  • Women who are pregnant or have a pregnancy plan within six months; Congenital adrenocortical hyperplasia; Hyperprolactinemia; Hyperthyroidism or hypothyroidism; Abnormal liver function (≥ 3 times the upper limit of the normal range); Abnormal renal function (GFR<60ml/min/1.73m2); Adrenal or ovarian tumors secreting androgens; Used contraceptives, metformin, pioglitazone, and antidepressant medication in the last 3 months.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Endocrinology, Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200070

Other trials in China

About this study

Official title: Treating Polycystic Ovarian Syndrome (PCOS) With Digital Intervention vs. Metformin

With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. In addition, research has shown that digital therapy can effectively improve behavior changes in diet, exercise, and medication adherence, predict disease progression, reduce the frequency of disease-related symptoms, and promote effective disease management. This study aimed to investigate the efficacy of digital intervention versus traditional metformin monotherapy in patients with PCOS.

Read the detailed description

This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.

Being tested
Digital Intervention, Metformin
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital InterventionBehavioural

    This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.

  • MetforminDrug

    Also called Metformin treatment

    Traditional metformin monotherapy.

Study groups in NCT05386706
Study groupRoleWhat they receive
Digital InterventionExperimentalA mini program-based digital intervention.
Receives: Behavioral: Digital Intervention
MetforminActive comparatorTraditional metformin monotherapy.
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Homeostasis model assessment of insulin resistance

    insulin resistance index

    Measured: 3 months

Secondary outcomes (17)

  1. Anthropometry

    body mass index (kg/m2)

    Measured: 3 months

  2. menstrual frequency

    number of menstruation in a year

    Measured: 3 months

  3. fasting glucose

    fasting glucose（mmol/L)

    Measured: 3 months

  4. fasting insulin

    fasting insulin（mmol/L)

    Measured: 3 months

  5. Total cholesterol

    Total cholesterol (mmol/L)

    Measured: 3 months

  6. Triglycerides

    Triglycerides (mmol/L)

    Measured: 3 months

  7. HDL-c

    HDL-c (mmol/L)

    Measured: 3 months

  8. LDL-c

    LDL-c (mmol/L)

    Measured: 3 months

  9. total testosterone

    total testosterone (nmol/L)

    Measured: 3 months

  10. free testosterone

    free testosterone (nmol/L)

    Measured: 3 months

  11. Sex hormone-binding globulin

    Sex hormone-binding globulin (nmol/L)

    Measured: 3 months

  12. Androstenedione

    Androstenedione (ng/ml)

    Measured: 3 months

  13. Dehydroepiandrosterone

    Dehydroepiandrosterone (ug/dl)

    Measured: 3 months

  14. International Physical Activity Questionnaire (IPAQ)

    Assess physical activity situation in women with PCOS.

    Measured: 3 months

  15. Pittsburgh Sleep Quality Index (PSQI)

    Assess sleep situation in women with PCOS.

    Measured: 3 months

  16. Hospital Anxiety and Depression Scale (HADS)

    To evaluate anxiety and depression in PCOS women.

    Measured: 3 months

  17. Three-Factor Eating Questionnaire (TFEQ-R21)

    Assess eating behavior in women with PCOS.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start21 Jun 2022
  3. Primary completion12 Aug 2023
  4. Study completion1 Sep 2023

Resources

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
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05386706
Sponsor's protocol ID
Digital Intervention PCOS
Status last verified
Nov 2023
First submitted
18 May 2022
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dilimulati D, Shao X, Wang L, Cai M, Zhang Y, Lu J, Wang Y, Liu H, Kuang M, Chen H, Zhang M, Qu S. Efficacy of WeChat-Based Digital Intervention Versus Metformin in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 2;26:e55883. doi: 10.2196/55883.

    PubMed 39357046

Questions about this trial

What is this clinical trial studying?

A study testing Digital Intervention and Metformin in people with Polycystic Ovary Syndrome, run by Shanghai 10th People's 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 1 inclusion and 1 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 13 Nov 2023. 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. 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?

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?

Homeostasis model assessment of insulin resistance (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05386706, which also lists 1 linked publication.

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 13 Nov 2023.

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