Polycystic Ovary Syndrome and BETATROPHIN

• Sponsor: Hatice Akkaya (Other)
• Overall Status: Completed
• CT.gov ID: NCT04448730
• Collaborator: (none)
• Enrollment: 73
• Location: 1
• Actual Duration (Months): 23.9
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary; Obesity	Diagnostic Test: serum marker levels

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 Design

• Study Type: Observational
• Actual Enrollment: 73 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Can the Betatrophin be a Reliable Marker of Insulin Resistance in Normal Weight and Overweight Women With Polycystic Ovary Syndrome?
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Jul 30, 2019
• Actual Study Completion Date: Dec 30, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. serum Betatrophin levels [30 min]

   ng/L

Secondary Outcome Measures

1. Waist/hip ratio [5 min]

   centimeter

2. 75 gr OGTT(oral glucose tolerance test) [2 hours]

   (mg/dl)

3. BMI (body mass index) [5 minute]

   kg/m2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kayseri Doğumevi	Kocasinan	Kayseri	Turkey	38090

Sponsors and Collaborators

• Hatice Akkaya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hatice Akkaya, associate professor, Kayseri Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT04448730
• Other Study ID Numbers: EZTB24
• First Posted: Jun 26, 2020
• Last Update Posted: Jun 26, 2020
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hatice Akkaya, associate professor, Kayseri Education and Research Hospital: Betatrophin; PCOS; obesity; insulin resistance
• Additional relevant MeSH terms: Polycystic Ovary Syndrome

Study Results

No Results Posted as of Jun 26, 2020