Metabolic Profile and Adipokine Levels in Young Hyperandr... | NCT05112029

Studies
Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females

NCT05112029

Sponsor

Medical University of Gdansk

Status

Unknown status

Last Update Posted

Nov 8, 2021Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Hyperandrogenism
Obesity
Metabolic Disease
Metabolic Syndrome

Interventions

Not provided

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2021Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Jun 2022Estimated

First Submitted Date

Oct 14, 2021

First Submission Date that Met QC Criteria

Oct 27, 2021

First Posted Date

Nov 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2021

Last Update Posted Date

Nov 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

male sex
no consent given

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Hyperandrogenemic females admitted for additional assessment due to medical reasons.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Agata Berlińska, MD	Contact	+48 58 584 48 05		agata.berlinska@gumed.edu.pl
Dominika Okroj, MD	Contact	+48 58 584 48 05		dominika.okroj@gumed.edu.pl

Overall Officials

Name	Affiliation	Role
Renata Świątkowska-Stodulska, MD PhD	Medical University of Gdansk	Study Director
Agata Berlińska, MD	Medical University of Gdansk	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology and Internal Medicine, Medical University of Gdansk	Recruiting	Gdansk			Poland

Condition Browse Module

MeSH Terms

ID	Term
D017588	Hyperandrogenism
D009765	Obesity
D008659	Metabolic Diseases
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D058489	46, XX Disorders of Sex Development
D012734	Disorders of Sex Development
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided