Clinical trial NCT05386706: Treating PCOS With Digital Intervention vs. Metformin
Official title: Treating Polycystic Ovarian Syndrome (PCOS) With Digital Intervention vs. Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Homeostasis model assessment of insulin resistance
timeFrame: 3 months
Secondary outcomes:
measure: Anthropometry
timeFrame: 3 months
measure: menstrual frequency
timeFrame: 3 months
measure: fasting glucose
timeFrame: 3 months
measure: fasting insulin
timeFrame: 3 months
measure: Total cholesterol
timeFrame: 3 months
measure: Triglycerides
timeFrame: 3 months
measure: HDL-c
timeFrame: 3 months
measure: LDL-c
timeFrame: 3 months
measure: total testosterone
timeFrame: 3 months
measure: free testosterone
timeFrame: 3 months
measure: Sex hormone-binding globulin
timeFrame: 3 months
measure: Androstenedione
timeFrame: 3 months
measure: Dehydroepiandrosterone
timeFrame: 3 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 3 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months
measure: Three-Factor Eating Questionnaire (TFEQ-R21)
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Shen Qu, Doctor
role: STUDY_CHAIR
References: