A Treatment Legacy Effect of Metformin in Obese Women With PCOS
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group A Obese women who have been treated with metformin for one year prior to the study. |
Drug: Metformin
metformin cessation
|
| Group B Obese women who have been treated with metformin for at least three years prior to the study. |
Drug: Metformin
metformin cessation
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Ljubljana | Ljubljana | Slovenia | 1000 |
Sponsors and Collaborators
- University Medical Centre Ljubljana
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MET prosp