A Treatment Legacy Effect of Metformin in Obese Women With PCOS

Study Overview
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Brief Summary
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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.

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

Conditions
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PCOS

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Obese women who have been treated with metformin for one year prior to the study. | Drug: Metformin<br>* metformin cessation<br>|
| Group B<br>Obese women who have been treated with metformin for at least three years prior to the study. | Drug: Metformin<br>* metformin cessation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 as the product of the fasting glucose and insulin concentration divided by 22.5. | HOMA IR was calculated at the base point and at the endpoint of 6 months of clinical trial. | 
| The main outcome was change in expression of glucose transporter type 4 (GLUT-4) in adipose tissue. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, obesity, metformin