A Treatment Legacy Effect of Metformin in Obese Women With PCOS

PCOS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566718
• Other study ID #: MET prosp
• Status: Completed
• Start date: March 25, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: November 2020
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2020
• Est. primary completion date: December 4, 2019
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• PCOS

Intervention

Drug:
• Metformin
metformin cessation

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.