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Completed

NCT Number: NCT04448730

Polycystic Ovary Syndrome and BETATROPHIN

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

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Key information

Conditions

Polycystic Ovary Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Signs and Symptoms Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Kayseri Doğumevi

Kocasinan, Kayseri, 38090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

serum marker levels

Diagnostic Test

two groups comparisons

Primary outcomes

  1. serum Betatrophin levels

    Time frame: 30 min

    ng/L

Secondary outcomes

  1. Waist/hip ratio

    Time frame: 5 min

    centimeter

  2. 75 gr OGTT(oral glucose tolerance test)

    Time frame: 2 hours

    (mg/dl)

  3. BMI (body mass index)

    Time frame: 5 minute

    kg/m2

Sponsors and collaborators

Lead sponsor

Hatice Akkaya

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2020
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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