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CompletedNCT04448730Updated Jun 26, 2020

Polycystic Ovary Syndrome and BETATROPHIN

An observational study in Polycystic Ovary and Obesity, sponsored by Hatice Akkaya. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-06-26.

Sponsored by Hatice Akkaya · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
73
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Polycystic Ovary
  • Obesity

Keywords

  • Betatrophin
  • PCOS
  • obesity
  • insulin resistance
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion 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.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
73 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1 (normal weight with PCOS )

    35 cases

    Diagnostic Test: serum marker levels

  • overweight PCOS

    38 cases

    Diagnostic Test: serum marker levels

Interventions

  • Diagnostic testserum marker levels

    two groups comparisons

05

What researchers measure

Primary outcomes

  1. serum Betatrophin levels

    ng/L

    Time frame: 30 min

Secondary outcomes

  1. Waist/hip ratio

    centimeter

    Time frame: 5 min

  2. 75 gr OGTT(oral glucose tolerance test)

    (mg/dl)

    Time frame: 2 hours

  3. BMI (body mass index)

    kg/m2

    Time frame: 5 minute

06

Study locations

1 site
  • Kayseri Doğumevi
    Kocasinan, Kayseri 38090, Turkey
07

References and documents

Individual participant data

Plan to share: Yes — If needed

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04448730
Lead sponsor
Hatice Akkaya
Responsible party
Hatice Akkaya (associate professor, Kayseri Education and Research Hospital) — Sponsor-investigator
First posted
Jun 26, 2020
Start date
Jan 1, 2018
Primary completion
Jul 30, 2019
Completion
Dec 30, 2019
Last update
Jun 26, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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