A Treatment Legacy Effect of Metformin in Obese Women With PCOS

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.

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Key information

Conditions

PCOS Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

metformin cessation

Primary outcomes

The main outcome was change in body weight.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

A Treatment Legacy Effect of Metformin on Metabolic and Endocrine Parameters in Obese Women With Polycystic Ovary Syndrome (PCOS)

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2020
First posted: Sep 28, 2020
Registry last updated: Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed