Clinical Trial on Obesity, Hyperandrogenism, Metabolic Syndrome, Metabolic Disease - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Contact

Name: Agata Berlińska, MD
Phone Number: +48 58 584 48 05
Email: agata.berlinska@gumed.edu.pl

Study Contact Backup

Name: Dominika Okroj, MD
Phone Number: +48 58 584 48 05
Email: dominika.okroj@gumed.edu.pl

Study Locations

Poland
- - Gdańsk, Poland
    - Recruiting
    - Department of Endocrinology and Internal Medicine, Medical University of Gdansk
    - Contact:
      
      Agata Berlińska, MD
    - Principal Investigator:
      
      Renata Świątkowska-Stodulska, MD PhD
    - Principal Investigator:
      
      Agata Berlińska, MD
    - Sub-Investigator:
      
      Dominika Okroj, MD
    - Sub-Investigator:
      
      Katarzyna Blatch, MD

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

Hyperandrogenemic females admitted for additional assessment due to medical reasons.

Description

Inclusion Criteria:

hyperandrogenemia
informed consent to participate
female sex
age 18-40 years old

Exclusion Criteria:

male sex
no consent given

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

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basic metabolic profile. Time Frame: Day of blood testing - no further assessment planned (observational study).	Serum lipids, uric acid, fasting glucose and insulin.	Day of blood testing - no further assessment planned (observational study).
Adipokines. Time Frame: Day of blood testing - no further assessment planned (observational study).		Day of blood testing - no further assessment planned (observational study).

Collaborators and Investigators

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

Sponsor

Medical University of Gdansk

Investigators

Study Director: Renata Świątkowska-Stodulska, MD PhD, Medical University of Gdańsk
Principal Investigator: Agata Berlińska, MD, Medical University of Gdańsk

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)

September 22, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)