NCT05246306

Brief Summary

Polycystic Ovary Syndrome (PCOS) is associated with hyperandrogenism, hyperinsulinemia and insulin resistance starting in the perimenarchal period. Insulin resistance also increases the risk of developing glucose intolerance, type 2 diabetes, hypertension, dyslipidemia and cardiovascular disorders. Studies on adult women with PCOS show that their aerobic capacity is affected. Therefore, in this study; it was aimed to compare the physical and cardiovascular fitness levels of adolescent PCOS patients with healthy adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

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
completed

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
4 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

January 21, 2022

Last Update Submit

October 9, 2022

Conditions

Keywords

aerobic capacityphysical fitness

Outcome Measures

Primary Outcomes (2)

  • Aerobic Exercise Capacity

    PACER running test, which is included in the fitnessgram test protocol, will be used to evaluate aerobic capacity.

    1 day

  • Physical Fitness

    The Fitnessgram Test Protocol will be used for physical fitness assessment.

    1 day

Secondary Outcomes (4)

  • Peripheral Muscle Strength

    1 day

  • Physical Activity Level

    1 day

  • Life quality

    1 day

  • Body composition analysis

    1 day

Study Arms (2)

Healthy group

Healthy adolescents aged 14-24 who have not been diagnosed with any chronic disease

Patient with PCOS group

Adolescents between the ages of 14-24 diagnosed with Polycystic Ovary Syndrome according to the Rotherdam criteria.

Eligibility Criteria

Age14 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy group: Being in the adolescent group, not having any chronic disease and being willing to participate in the study. Patient group: Being in the adolescent group, being diagnosed with polycystic ovary syndrome and being willing to participate in the study

You may qualify if:

  • Being between the ages of 14-24,
  • Collecting Polycystic Syndrome according to Rotherdam,
  • Not having had Covid-19.

You may not qualify if:

  • Not to be between the ages of 14-24,
  • Not showing the symptoms of Polycystic Ovary Syndrome (PCOS),
  • Having had Covid-19,
  • Having a chronic disease diagnosed other than PCOS,
  • Having cognitive impairment that will affect their cooperation with tests.
  • Being a female adolescent between the ages of 14-24,
  • Not having been diagnosed with any chronic disease,
  • Adolescents with regular menstrual cycles,
  • Not taking any medication known to affect hormone, lipid and carbohydrate metabolism,
  • Not having clinical signs of hyperandrogenism,
  • Not having had Covid-19.
  • Not to be between the ages of 14-24,
  • Having a chronic disease,
  • Having had Covid-19,
  • Having cognitive impairment that will affect their cooperation with tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ebru Calik Kutukcu, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 18, 2022

Study Start

September 22, 2021

Primary Completion

September 21, 2022

Study Completion

September 21, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations