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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Obese women who have been treated with metformin for one year prior to the study. |
| |
| Group B | Obese women who have been treated with metformin for at least three years prior to the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | metformin cessation |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ljubljana | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33845893 | Derived | Kravos NA, Janez A, Goricar K, Dolzan V, Jensterle M. Effects of metformin withdrawal after long and short term treatment in PCOS: observational longitudinal study. Diabetol Metab Syndr. 2021 Apr 12;13(1):43. doi: 10.1186/s13098-021-00660-5. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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adipose tissue
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |