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Treating Obese PCOS Patients With LSG vs. Met

T

Tongji University

Status and phase

Invitation-only
Phase 4

Conditions

Polycystic Ovary Syndrome

Treatments

Procedure: laparoscopic sleeve gastrectomy
Drug: Metformin Pill

Study type

Interventional

Funder types

Other

Identifiers

NCT04508634
LSG vs. Met in PCOS

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

90 participants in 2 patient groups

laparoscopic sleeve gastrectomy
Experimental group
Description:
laparoscopic sleeve gastrectomy
Treatment:
Procedure: laparoscopic sleeve gastrectomy
Metformin Group
Active Comparator group
Description:
Metformin Group
Treatment:
Drug: Metformin Pill

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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