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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
Sponsor:
Information provided by (Responsible Party):
Sara Saad Youssef Morsi, Ain Shams Maternity Hospital

Brief Summary:

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
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Cases
Polycystic ovary syndrome (PCOS) female patients. 20-35 years of age.
Controls
Non-PCOs female subjects. 20-35 years of age.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Fasting Plasma Insulin [ Time Frame: 12 hours of fasting. ]
    Overnight fasting venous samples

  2. Fasting Plasma Glucose [ Time Frame: 12 hours of fasting. ]
    Overnight fasting venous samples.

  3. 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
Overnight fasting venous blood samples will be withdrawn between the 2nd and 3rd day of menstruation, and withdrawal bleeding following progesterone therapy for 5 days in amenorheic women, centrifuged and frozen to -80 C until analyzed for the assessment of vitamin D levels, Androgen levels, plasma Glucose and plasma Insulin, FSH and LH analogues.


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
In this study, a total of 166 consenting women with and without PCOS will be asked to participate and divided into two groups; 83 female patients will represent PCOS recruited from the outpatient clinics of Ain Shams university maternity hospital, along with 83 non-PCOS women who will represent controls recruited after fulfilling specific criteria.
Criteria

PCOS female patients criteria:

Inclusion Criteria:

  • PCOS will be diagnosed in accordance with Rotterdam criteria.
  • No relevant systemic diseases e.g. hypertension, DM.

Exclusion Criteria:

  • Androgen secreting tumor.
  • Cushing syndrome.
  • Congenital adrenal hyperplasia.
  • Hyperprolactinemia.
  • Virilism.
  • Pregnant or nursing.
  • Conditions known to affect Vitamin D deficiency like renal disease, liver disease, gastrointestinal problems and malnutrition.
  • Taking vitamin D or calcium supplements.
  • Untreated hypothyroidism or hyperthyroidism.

Non-PCOS female subjects criteria:

  • Regular menstrual cycles
  • Not suffering from any conditions known to affect Vitamin D deficiency like renal disease, liver disease, gastro-Intestinal problems and malnutrition.
  • Not taking vitamin D or calcium supplements.
  • No relevant systemic diseases e.g. hypertension, DM.

Information from the National Library of Medicine

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


Contacts
Contact: Sara S Youssef, MD +201005049994 sara.saad@mail.com
Contact: Sherif A Ashoush, Phd, MD +201222660266 sherifashoush@hotmail.com

Locations
Egypt
Ain Shams University Maternity Hospital Recruiting
Cairo, Abbasseya district., Egypt, 11566
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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

Publications of Results:

Other Publications:

Responsible Party: Sara Saad Youssef Morsi, MD, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02803476     History of Changes
Other Study ID Numbers: 2732016
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Sara Saad Youssef Morsi, Ain Shams Maternity Hospital:
PCO
Vitamin D
Insulin resistance

Additional relevant MeSH terms:
Syndrome
Insulin Resistance
Polycystic Ovary Syndrome
Vitamin D Deficiency
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Insulin
Vitamins
Vitamin D
Ergocalciferols
Hypoglycemic Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Bone Density Conservation Agents