A Treatment Legacy Effect of Metformin in Obese Women With PCOS

NCT04566718 | Completed

• 1 other identifier: MET prosp
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS

Keywords

PCOS; obesity; metformin

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Group A

Obese women who have been treated with metformin for one year prior to the study.

Drug: Metformin

Group B

Obese women who have been treated with metformin for at least three years prior to the study.

Drug: Metformin

Interventions

Metformin DRUG

metformin cessation

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 33845893 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

adipose tissue

MeSH Terms

Conditions

Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: March 25, 2019
• Primary Completion: December 4, 2019
• Study Completion: February 1, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

SL (1)