Is There Association Between Vitamin D Levels And Insulin Resistance In Polycystic Ovary Syndrome?
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|ClinicalTrials.gov Identifier: NCT02803476|
Recruitment Status : Unknown
Verified June 2016 by Sara Saad Youssef Morsi, Ain Shams Maternity Hospital.
Recruitment status was: Recruiting
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
The primary aim of the current study is to clarify whether serum vitamin D levels [25(OH)D3] have a temporal association with insulin resistance and/or insulin sensitivity in PCOS women versus healthy ones.
To achieve this aim, the investigators will conduct a prospective observational study involving obese and lean PCOS women in comparison to obese and lean healthy subjects living in Cairo, Egypt.
|Condition or disease|
|Polycystic Ovary Syndrome Insulin Resistance Vitamin D Deficiency|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||166 participants|
|Observational Model:||Case Control|
|Official Title:||Is There An Association Between Vitamin D Levels And Insulin Resistance In Polycystic Ovary Syndrome?|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||August 2016|
Polycystic ovary syndrome (PCOS) female patients. 20-35 years of age.
Non-PCOs female subjects. 20-35 years of age.
- Quantitative Insulin Sensitivity Check Index (QUICKI) [ Time Frame: After sample collection and analysis, through study completion, an average of 20 weeks. ]A validated measure of Insulin sensitivity based on fasting Insulin (uIU/mL) and Glucose (mg/dL).
- Fasting Plasma Insulin [ Time Frame: 12 hours of fasting. ]Overnight fasting venous samples
- Fasting Plasma Glucose [ Time Frame: 12 hours of fasting. ]Overnight fasting venous samples.
- Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: After sample collection and analysis, through study completion, an average of 20 weeks. ]A validated measure of Insulin sensitivity based on fasting Insulin (uIU/mL) and Glucose (mg/dl)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803476
|Contact: Sara S Youssef, MDfirstname.lastname@example.org|
|Contact: Sherif A Ashoush, Phd, MDemail@example.com|
|Ain Shams University Maternity Hospital||Recruiting|
|Cairo, Abbasseya district., Egypt, 11566|
|Study Chair:||Hisham M Fathi, Phd , MD||Professor of Obstetrics & Gynecology. Faculty of Medicine - Ain Shams University.|
|Study Director:||Sherif A Ashoush, Phd, MD||Professor of Obstetrics & Gynecology. Faculty of Medicine - Ain Shams University.|
|Principal Investigator:||Sara S Youssef, MD||MD, Obstetrics and Gynecology. Faculty of Medicine - Ain Shams University|