NCT03587415

Brief Summary

Preptin and amylin are pancreatic hormones which participate in glucose homeostasis. This study aims to evaluate how serum preptin and amylin levels are altered in polycystic ovary syndrome (PCOS) patients and healthy women based on BMI groups .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

June 12, 2018

Last Update Submit

July 13, 2018

Conditions

Keywords

amylin; obesity; polycystic ovarian syndrome; preptin

Outcome Measures

Primary Outcomes (1)

  • Serum Preptin and Amylin Levels with Respect to Body Mass Index in Polycystic Ovary Syndrome Patients

    Serum Preptin and Amylin Levels will compare between groups

    six months

Study Arms (2)

Polycyctic ovary sendrome (PCOS)

these women who have PCOS, we will use their blood samples

Diagnostic Test: preptin and amylin level

Healty groups

These women who have reguler menstrual cycle, no akne or hirsutism, we will use their boold samples

Diagnostic Test: preptin and amylin level

Interventions

we will take both of group blood samples to compare them serum preptin and amylin

Healty groupsPolycyctic ovary sendrome (PCOS)

Eligibility Criteria

Age17 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Polycystic ovary syndrome

You may qualify if:

  • the patients with PCOS

You may not qualify if:

  • Cushing's syndrome 21-hydroxylase deficiency Congenital adrenal hyperplasia Thyroid dysfunction Hyperprolactinemia Diabetes Chronic cardiovascular Hepatic, renal, and hematologic diseases Malignancies Using oral contraceptives, anti-androgens, glucocorticoids, anti-hypertensives, anti-diabetics, calcium supplements and anti-obesity drugs and those who smoke or consume alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University

Rize, 53000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeObesity

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Senol sentürk, PhD

    Recep Tayyip Erdogan University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Serum Preptin and Amylin Levels in Polycystic Ovary Syndrome Patients

Study Record Dates

First Submitted

June 12, 2018

First Posted

July 16, 2018

Study Start

June 28, 2017

Primary Completion

November 30, 2017

Study Completion

December 7, 2017

Last Updated

July 16, 2018

Record last verified: 2018-07

Locations