Polycystic Ovary Syndrome and BETATROPHIN

NCT04448730 | Completed DMC

• 1 other identifier: EZTB24
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovary; Obesity

Keywords

Betatrophin; PCOS; obesity; insulin resistance

Outcome Measures

Primary Outcomes (1)

• serum Betatrophin levels

  ng/L

  30 min

Secondary Outcomes (3)

• Waist/hip ratio

  5 min

• 75 gr OGTT(oral glucose tolerance test)

  2 hours

• BMI (body mass index)

  5 minute

Study Arms (2)

Group 1 (normal weight with PCOS )

35 cases

Diagnostic Test: serum marker levels

overweight PCOS

38 cases

Diagnostic Test: serum marker levels

Interventions

serum marker levels DIAGNOSTIC_TEST

two groups comparisons

Group 1 (normal weight with PCOS ); overweight PCOS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hatice Akkaya: lead

Study Sites (1)

Kayseri Doğumevi

Kocasinan, Kayseri, 38090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: January 1, 2018
• Primary Completion: July 30, 2019
• Study Completion: December 30, 2019
• Last Updated: June 26, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: journals editors request

Locations

TU (1)