Polycystic Ovary Syndrome and BETATROPHIN

June 23, 2020 updated by: Hatice Akkaya

Can the Betatrophin be a Reliable Marker of Insulin Resistance in Normal Weight and Overweight Women With Polycystic Ovary Syndrome?

This is an original study giving an information about the association body mass index, polycystic ovary syndrome and betatrophin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: Betatrophin is a protein hormone which has a significant role in glucose homeostasis and lipid metabolism. The aim of this study is to compare the levels of serum betatrophin in overweight and normal weight women with PCOS.

Material and Method: Thirty-five patients normal weight women with PCOS (BMI<25) and 38 obese women with PCOS (BMI≥25) were included in this prospective, cross-sectional study. Patients were selected according to Rotterdam criteria. Serum betatrophin levels were studied by ELISA method and then compared between these two groups besides the following additional parameters as waist circumference/hip circumference ratio, fasting blood glucose, 75 g OGTT (oral glucose tolerance test) results and HOMA-IR levels.

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kayseri
      • Kocasinan, Kayseri, Turkey, 38090
        • Kayseri Doğumevi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Comparison of the Betatrohin serum marker of insulin resistance in normal weight and overweight women with polycystic ovary syndrome cases.

Description

Inclusion Criteria:

-Polycystic ovary syndrome according to 2003 Rotterdam PCOS Consensus diagnostic criteria

Exclusion criteria

  • pregnancy,
  • an additional systemic disease (i.e.,hyperprolactinemia, thyroid dysfunction, liver or kidney diseases, cardiovascular disease, hyperlipidemia, type 1 or type 2 diabetes, chronic or acute infection within the previous 30 days),
  • morbid obesity,
  • smoking,
  • the use of medications for contraception, androgen excess, hypertension, hyperglycemia or dyslipidemia at least 3 months before the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 (normal weight with PCOS )
35 cases
Diagnostic test: serum marker levels
two groups comparisons
overweight PCOS
38 cases
Diagnostic test: serum marker levels
two groups comparisons

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum Betatrophin levels
Time Frame: 30 min
ng/L
30 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI (body mass index)
Time Frame: 5 minute
kg/m2
5 minute
Waist/hip ratio
Time Frame: 5 min
centimeter
5 min
75 gr OGTT(oral glucose tolerance test)
Time Frame: 2 hours
(mg/dl)
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hatice Akkaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EZTB24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If needed

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

journals editors request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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