A Treatment Legacy Effect of Metformin in Obese Women With PCOS

Completed

• Conditions: PCOS
• Interventions: Drug: Metformin

• Registration Number: NCT04566718
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

Metformin has multiple health promoting effects and it may serve as a preventive measure for individuals who are at high risk for metabolic complications.

According to the latest international guidelines it should be considered as an adjunct therapy to lifestyle intervention in all overweight/obese women with PCOS, independently of their glucose homeostasis and menstrual regularity. However, there is no clear answer for how long metformin should be prescribed in this subset of women with PCOS and for how long the beneficial impact would sustain after treatment cessation.

The investigators compared the consequences of metformin withdrawal after long-term therapy as opposed to the consequences of metformin suspension after short term therapy in overweight/obese women with PCOS that had previously responded to metformin by means of moderate weight loss, improved menstrual frequency and sustained normal glucose homeostasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-25
• Primary Completion: 2019-12-04
• Study Completion: 2020-02-01
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• PCOS defined by the National Institute of Child Health and Human Development (NICHD) criteria
• obesity with body mass index ≥ 30 kg/m2
• normal glucose homeostasis at metformin treatment

Exclusion Criteria

• known type 1 or type 2 diabetes mellitus
• heart failure
• renal insufficiency with serum creatinine more than 125 umol/L
• arterial hypertension
• pregnancy
• BMI below 25 kg/m2

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Metformin	Obese women who have been treated with metformin for one year prior to the study.
Group B	Metformin	Obese women who have been treated with metformin for at least three years prior to the study.

Primary Outcome Measures

Name	Time	Method
The main outcome was change in body weight.	Patient's body weight was measured at the base point and at the endpoint of 6 months of clinical trial.
The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR).	HOMA IR was calculated at the base point and at the endpoint of 6 months of clinical trial.	HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22.5.
The main outcome was change in expression of glucose transporter type 4 (GLUT-4) in adipose tissue.	We did adipose tissue needle biopsy at the base point and at the endpoint of 6 months of clinical trial. All samples were frozen and then analysed together after end point of the study.	We obtained adipose tissue using needle biopsy, from which we isolated ribonucleic acid and after reverse transcription, real-time quantitative polymerase chain reaction determined messenger ribonucleic acid expression for GLUT-4.

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia