A Treatment Legacy Effect of Metformin in Obese Women With PCOS
NCT ID: NCT04566718
Last Updated: 2020-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2019-03-25
2020-02-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A
Obese women who have been treated with metformin for one year prior to the study.
Metformin
metformin cessation
Group B
Obese women who have been treated with metformin for at least three years prior to the study.
Metformin
metformin cessation
Interventions
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Metformin
metformin cessation
Eligibility Criteria
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Inclusion Criteria
* obesity with body mass index ≥ 30 kg/m2
* normal glucose homeostasis at metformin treatment
Exclusion Criteria
* heart failure
* renal insufficiency with serum creatinine more than 125 umol/L
* arterial hypertension
* pregnancy
* BMI below 25 kg/m2
18 Years
55 Years
FEMALE
No
Sponsors
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University Medical Centre Ljubljana
OTHER
Responsible Party
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Andrej Janez
Clinical Professor
Locations
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University Medical Center Ljubljana
Ljubljana, , Slovenia
Countries
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References
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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.
Other Identifiers
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MET prosp
Identifier Type: -
Identifier Source: org_study_id