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Completed

NCT Number: NCT05386706

Treating 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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200070, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Digital Intervention

Behavioral

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

metformin

Drug

Traditional metformin monotherapy.

Other names: Metformin treatment

Primary outcomes

  1. Homeostasis model assessment of insulin resistance

    Time frame: 3 months

    insulin resistance index

Secondary outcomes

  1. Anthropometry

    Time frame: 3 months

    body mass index (kg/m2)

  2. menstrual frequency

    Time frame: 3 months

    number of menstruation in a year

  3. fasting glucose

    Time frame: 3 months

    fasting glucose（mmol/L)

  4. fasting insulin

    Time frame: 3 months

    fasting insulin（mmol/L)

  5. Total cholesterol

    Time frame: 3 months

    Total cholesterol (mmol/L)

  6. Triglycerides

    Time frame: 3 months

    Triglycerides (mmol/L)

  7. HDL-c

    Time frame: 3 months

    HDL-c (mmol/L)

  8. LDL-c

    Time frame: 3 months

    LDL-c (mmol/L)

  9. total testosterone

    Time frame: 3 months

    total testosterone (nmol/L)

  10. free testosterone

    Time frame: 3 months

    free testosterone (nmol/L)

  11. Sex hormone-binding globulin

    Time frame: 3 months

    Sex hormone-binding globulin (nmol/L)

  12. Androstenedione

    Time frame: 3 months

    Androstenedione (ng/ml)

  13. Dehydroepiandrosterone

    Time frame: 3 months

    Dehydroepiandrosterone (ug/dl)

  14. International Physical Activity Questionnaire (IPAQ)

    Time frame: 3 months

    Assess physical activity situation in women with PCOS.

  15. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 3 months

    Assess sleep situation in women with PCOS.

  16. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 3 months

    To evaluate anxiety and depression in PCOS women.

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

    Time frame: 3 months

    Assess eating behavior in women with PCOS.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 23, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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