Treating Obese PCOS Patients With LSG vs. Met

Polycystic Ovary Syndrome Clinical Trial

Official title:

Comparison of the Clinical Efficacy of Laparoscopic Sleeve Gastrectomy and Metformin in the Treatment of Obese Patients With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04508634
• Other study ID #: LSG vs. Met in PCOS
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: November 1, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2023
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Sleeve gastrectomy was an effective threapy for severe obesity patients. This study will evaluate the clinical efficacy of sleeve gastrectomy for obese patients with PCOS. Mealwhile, the specific mechanism of sleeve gastrectomy for improving obese patients with PCOS will be explored through multi-group analysis.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: September 30, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• female aged 18- 45;
• meet Rotterdam criteria;
• BMI = 28 kg /m2.

Exclusion Criteria:

• Women who are pregnant or have a pregnancy plan within six months;
• Women who are reluctant to undergo metabolic surgery;
• Congenital adrenocortical hyperplasia;
• Hyperprolactinemia;
• Hyperthyroidism or hypothyroidism;
• Abnormal liver function (= 3 times of the upper limit of normal range); abnormal · Rrenal function (GFR<60ml/min/1.73m2);
• Adrenal or ovarian tumors secreting androgens;
• Used contraceptives, metformin, GLP-1RA, pioglitazone and contraceptives in the last 3 month.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Procedure:
• laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy

Drug:
• Metformin Pill
Metformin 1000mg bid

Locations

Country	Name	City	State
China	Shanghai Tenth People' Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HOMA-IR	Insulin resistance index	3 months
Primary	Screening of metabolites in plasma concentration in fasting condition	The investigators will perform metabolites to identify the changes that may give rise to the disease.	3 months
Primary	Screening of transcriptome profile in plasma concentration in fasting condition	The investigators will perform transcriptome profile to identify the changes that may give rise to the disease.	3 months
Primary	Screening of Microbiome in faeces	The investigators will perform Microbiome to identify the changes that may give rise to the disease.	3 months
Secondary	menstrual cycles	menstrual frequency	3 months
Secondary	Gonadotropin level	LH(IU/L) , FSH (IU/L),	3 months
Secondary	testosterone	total testosterone (nmol/L), testosterone (nmol/L)	3 months
Secondary	SHBG level	SHBG (nmol/L).	3 months
Secondary	FINS	fasting insulin (IU/L)	3 months
Secondary	TC	Total cholesterol (mmol/L)	3 months
Secondary	TG	Triglycerides (mmol/L)	3 months
Secondary	HDL-c	high-density lipoprotein cholesterol (mmol/L)	3 months
Secondary	LDL-c	low-density lipoprotein cholesterol (mmol/L)	3 months