An observational study in PCOS, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-11-05.
Sponsored by University Medical Centre Ljubljana · Observational
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.
University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.
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The investigators conducted 20 obese women with PCOS with normal glucose homeostasis (without known type 1 or type 2 diabetes mellitus) who have been treated with metformin for one year prior to the study and 20 obese women with PCOS with normal glucose homeostasis (without known type 1 or type 2 diabetes mellitus) who have been treated with metformin for at least three years prior to the study.
Exclusion Criteria:
Obese women who have been treated with metformin for one year prior to the study.
Drug: Metformin
Obese women who have been treated with metformin for at least three years prior to the study.
Drug: Metformin
metformin cessation
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).
HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22.5.
Time frame: 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.
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.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University Medical Centre Ljubljana