NCT05112029

Brief Summary

Assessement of basic metabolic profile and adipokine levels in young hyperandrogenemic females.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

October 14, 2021

Last Update Submit

October 27, 2021

Conditions

HyperandrogenismObesityMetabolic DiseaseMetabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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).

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Hyperandrogenemic females admitted for additional assessment due to medical reasons.

You may qualify if:

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

You may not qualify if:

  • male sex
  • no consent given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology and Internal Medicine, Medical University of Gdansk

Gdansk, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Deep frozen plasma and serum.

MeSH Terms

Conditions

HyperandrogenismObesityMetabolic DiseasesMetabolic Syndrome

Condition Hierarchy (Ancestors)

46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Study Officials

  • Renata Świątkowska-Stodulska, MD PhD

    Medical University of Gdansk

    STUDY DIRECTOR

  • Agata Berlińska, MD

    Medical University of Gdansk

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agata Berlińska, MD

CONTACT

+48 58 584 48 05agata.berlinska@gumed.edu.pl

Dominika Okroj, MD

CONTACT

+48 58 584 48 05dominika.okroj@gumed.edu.pl

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2021

First Posted

November 8, 2021

Study Start

September 22, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

November 8, 2021

Record last verified: 2021-10

Locations

PL(1)