Is There Association Between Vitamin D Levels And Insulin Resistance In Polycystic Ovary Syndrome?

NCT02803476 | Unknown DMC

• 1 other identifier: 2732016
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Insulin Resistance; Vitamin D Deficiency

Keywords

PCO; Vitamin D; Insulin resistance

Outcome Measures

Primary Outcomes (1)

• Quantitative Insulin Sensitivity Check Index (QUICKI)

  A validated measure of Insulin sensitivity based on fasting Insulin (uIU/mL) and Glucose (mg/dL).

  After sample collection and analysis, through study completion, an average of 20 weeks.

Secondary Outcomes (3)

• Fasting Plasma Insulin

  12 hours of fasting.

• Fasting Plasma Glucose

  12 hours of fasting.

• Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

  After sample collection and analysis, through study completion, an average of 20 weeks.

Study Arms (2)

Cases

Polycystic ovary syndrome (PCOS) female patients. 20-35 years of age.

Controls

Non-PCOs female subjects. 20-35 years of age.

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Abbasseya District., 11566, Egypt

RECRUITING

Related Publications (31)

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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.

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Officials

• Hisham M Fathi, Phd, MD

  Professor of Obstetrics & Gynecology. Faculty of Medicine - Ain Shams University.

  STUDY CHAIR

• Sherif A Ashoush, Phd, MD

  Professor of Obstetrics & Gynecology. Faculty of Medicine - Ain Shams University.

  STUDY DIRECTOR

• Sara S Youssef, MD

  MD, Obstetrics and Gynecology. Faculty of Medicine - Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara S Youssef, MD

CONTACT

+201005049994; sara.saad@mail.com

Sherif A Ashoush, Phd, MD

CONTACT

+201222660266; sherifashoush@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 17, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)