HyperandrogenismNCT05112029
Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females
An observational study of Hyperandrogenism and Obesity, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Assessement of basic metabolic profile and adipokine levels in young hyperandrogenemic females. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hyperandrogenism, Obesity, Metabolic Disease
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 22 Sep 2021to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Hyperandrogenemic females admitted for additional assessment due to medical reasons.
Who may be able to join
- hyperandrogenemia
- informed consent to participate
- female sex
- age 18-40 years old
Who cannot join
- male sex
- no consent given
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Internal Medicine, Medical University of Gdansk
Gdansk
Agata Berlińska, MD
Renata Świątkowska-Stodulska, MD PhD
About this study
Assessement of basic metabolic profile and adipokine levels in young hyperandrogenemic females.
- Conditions
- Hyperandrogenism, Obesity, Metabolic Disease, Metabolic Syndrome
- Medical subject headings
- Hyperandrogenism, Obesity, Metabolic Diseases, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Basic metabolic profile.
Serum lipids, uric acid, fasting glucose and insulin.
Measured: Day of blood testing - no further assessment planned (observational study).
Adipokines.
Measured: Day of blood testing - no further assessment planned (observational study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start22 Sep 2021
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperandrogenismStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renata Świątkowska-Stodulska, MD PhD, Study director, Medical University of GdanskAgata Berlińska, MD, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112029
- Sponsor's protocol ID
- ADIP-AN
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females
- ClinicalTrials.gov ID
- NCT05112029
- Acronym / sponsor ID
- ADIP-AN
- Conditions
- Hyperandrogenism, Obesity, Metabolic Disease, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessement of basic metabolic profile and adipokine levels in young hyperandrogenemic females.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Hyperandrogenemic females admitted for additional assessment due to medical reasons.
Key inclusion criteria (4 listed)
- hyperandrogenemia
- informed consent to participate
- female sex
- age 18-40 years old
Key exclusion criteria (2 listed)
- male sex
- no consent given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Basic metabolic profile.
Time frame: Day of blood testing - no further assessment planned (observational study).
Serum lipids, uric acid, fasting glucose and insulin.
Adipokines.
Time frame: Day of blood testing - no further assessment planned (observational study).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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Recruiting
Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
PCOS (Polycystic Ovary Syndrome), Obese Adolescents
Recruiting
This Study Aims to Evaluate Whether Milamend's Product Could Improve Hormone Balance in Women Who Suffer From Self-reported PCOS Symptoms.
Polycystic Ovarian Syndrome (PCOS)
Not yet recruitingObservational study
Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS)
Polycystic Ovary Syndrome (PCOS), Metabolic Dysfunction-Associated Steatotic Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Świątkowska-Stodulska, MD PhD study director
Medical University of Gdansk
Agata Berlińska, MD principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperandrogenism and Obesity, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agata Berlińska, MD (+48 58 584 48 05, agata.berlinska@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basic metabolic profile. (time frame: Day of blood testing - no further assessment planned (observational study).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.