Treating PCOS With Digital Intervention vs. Metformin

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Behavioral: Digital Intervention; Drug: Metformin

• Registration Number: NCT05386706
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-23
• Study Start: 2022-06-21
• Primary Completion: 2023-08-12
• Study Completion: 2023-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Intervention	Digital Intervention	A mini program-based digital intervention.
Metformin	Metformin	Traditional metformin monotherapy.

Primary Outcome Measures

Name	Time	Method
Homeostasis model assessment of insulin resistance	3 months	insulin resistance index

Secondary Outcome Measures

Name	Time	Method
fasting insulin	3 months	fasting insulin（mmol/L)
Total cholesterol	3 months	Total cholesterol (mmol/L)
total testosterone	3 months	total testosterone (nmol/L)
free testosterone	3 months	free testosterone (nmol/L)
Pittsburgh Sleep Quality Index (PSQI)	3 months	Assess sleep situation in women with PCOS.
fasting glucose	3 months	fasting glucose（mmol/L)
menstrual frequency	3 months	number of menstruation in a year
Triglycerides	3 months	Triglycerides (mmol/L)
HDL-c	3 months	HDL-c (mmol/L)
LDL-c	3 months	LDL-c (mmol/L)
Anthropometry	3 months	body mass index (kg/m2)
Sex hormone-binding globulin	3 months	Sex hormone-binding globulin (nmol/L)
Androstenedione	3 months	Androstenedione (ng/ml)
Dehydroepiandrosterone	3 months	Dehydroepiandrosterone (ug/dl)
International Physical Activity Questionnaire (IPAQ)	3 months	Assess physical activity situation in women with PCOS.
Hospital Anxiety and Depression Scale (HADS)	3 months	To evaluate anxiety and depression in PCOS women.
Three-Factor Eating Questionnaire (TFEQ-R21)	3 months	Assess eating behavior in women with PCOS.

Trial Locations

Locations (1)

Department of Endocrinology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China