NCT02126592

Brief Summary

Polycystic ovary syndrome (PCOS) is an endocrine disease in reproductive women. It is characterized by anovulation and hyperandrogenism. Most patients with PCOS have metabolic abnormalities such as dyslipidemia, insulin resistance and glucose abnormalities. Almost 60-80﹪PCOS patients are obesity which exacerbates IR and hyperandrogenism. Obese PCOS patients tend to be overeating suggests that impaired appetite regulation might be contribute to the pathophysiology of PCOS. Our study is trying to observe difference of incretin between PCOS and normal control to figure out whether change of incretin is involved in the pathophysiology of PCOS.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 30, 2014

Status Verified

January 1, 2014

Enrollment Period

1.1 years

First QC Date

January 21, 2014

Last Update Submit

April 28, 2014

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in incretin hormones secretion in PCOS patients.

    up to 14 months

Study Arms (2)

PCOS cohort

Women with PCOS

Control cohort

Women without PCOS

Eligibility Criteria

Age13 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Polycystic Ovary Syndrome(PCOS)

You may qualify if:

  • women at reproductive age
  • women with PCOS and women without PCOS

You may not qualify if:

  • young women who had their menarche less than 3 years
  • women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, 200001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

only plasma

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

Central Study Contacts

Jing Ma, Dr.

CONTACT

+86-21-68383083cherry1996@live.cn

Study Design

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

Study Record Dates

First Submitted

January 21, 2014

First Posted

April 30, 2014

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

April 30, 2014

Record last verified: 2014-01

Locations

CN(1)