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Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women (U-C OC IN PCOS)

Primary Purpose

Polycystic Ovarian Syndrome

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Metformin 850 mg twice daily for 3 months
Serum uc-oc
drug
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome focused on measuring PCOS

Eligibility Criteria

20 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Lean women BMI 25 or less
  • Hyperandrogenic clinically and/or biochemically.
  • Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria

Exclusion Criteria:

  • BMI more than 20
  • Other causes of hyperandrogenism
  • Other causes of metabolic disorders or diabetes.

Sites / Locations

  • Nesreen Abdel Fattah Abdullah ShehataRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Metformin

Serum under-carboxylated osteocalcin

Placebo

Arm Description

Cidophage 850 mg twice daily for three months will be given to the patientwith PCOS.

Serum uc-oc will be measured before and after 3 months of treatment with cidophage.

Other group of patients with high serum UC-OC will be given a placebo.

Outcomes

Primary Outcome Measures

High Serum under-carboxylated osteocalcin
Hyperandrogenic lean women will be diagnosed as PCOS according to Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.Serum uc-oc will be assayed when it is found to be high, metformin therapy for three months will be given to these women. Serum uc-oc will be measured again and effect of therapy will be interpreted.

Secondary Outcome Measures

Metformin therapy
Cidophage 850 mg twice daily will be given for three months to pcos patients who are hyperandrogenic and lean then serum uc-oc will be measured after therapy.

Full Information

First Posted
September 13, 2014
Last Updated
January 30, 2021
Sponsor
Beni-Suef University
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02244567
Brief Title
Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women
Acronym
U-C OC IN PCOS
Official Title
Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin in Hyperandrogenic Lean PCOS Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
Collaborators
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women trying to interfere with the pathophysiology of PCOS in these women as followed up by serum UC-OC levels.
Detailed Description
Under-carboxylated osteocalcin (ucOC), the precursor substrate of bone biomarker OC is a potent regulator of energy metabolism by promoting insulin production and adiponectin synthesis and decreasing fat stores.UcOC has a potential role in the physiopathology of polycystic ovary syndrome (PCOS), a common disorder defined by the constellation of anovulation, insulinresistance, hyperinsulinemia, obesity and androgen excess.Circulating ucOC concentration is related to key endocrine PCOS characteristics in a weight-dependent manner. Within the bone-pancreas loop, high ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity.We will investigate serum uc-OC responses to insulin sensitizing therapies in lean hyperandrogenic polycystic ovary syndrome (PCOS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome
Keywords
PCOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Cidophage 850 mg twice daily for three months will be given to the patientwith PCOS.
Arm Title
Serum under-carboxylated osteocalcin
Arm Type
Active Comparator
Arm Description
Serum uc-oc will be measured before and after 3 months of treatment with cidophage.
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Other group of patients with high serum UC-OC will be given a placebo.
Intervention Type
Drug
Intervention Name(s)
Metformin 850 mg twice daily for 3 months
Other Intervention Name(s)
Cidophage
Intervention Description
This drug is insulin sensitizing agent which will be given twice daily orally for 3 months for PCOS patients.
Intervention Type
Procedure
Intervention Name(s)
Serum uc-oc
Other Intervention Name(s)
Serum undercarboxylated-osteocalcin
Intervention Description
Serum uc-oc is a bone biomarker involved in incraesing insulin in pathophysiology of PCOS. It will be measured in serum of pcos patients before and after treatment with metformin for 3 months.
Intervention Type
Other
Intervention Name(s)
drug
Other Intervention Name(s)
vitamin
Intervention Description
This group of patients will receive any type of vitamin as a placebo to compare with effect of Metformin on serum UC-OC.
Primary Outcome Measure Information:
Title
High Serum under-carboxylated osteocalcin
Description
Hyperandrogenic lean women will be diagnosed as PCOS according to Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.Serum uc-oc will be assayed when it is found to be high, metformin therapy for three months will be given to these women. Serum uc-oc will be measured again and effect of therapy will be interpreted.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Metformin therapy
Description
Cidophage 850 mg twice daily will be given for three months to pcos patients who are hyperandrogenic and lean then serum uc-oc will be measured after therapy.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lean women BMI 25 or less Hyperandrogenic clinically and/or biochemically. Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria Exclusion Criteria: BMI more than 20 Other causes of hyperandrogenism Other causes of metabolic disorders or diabetes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nesreen A Shehata, MD
Phone
00201227866337
Email
nesoomar@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelgany M Hassan, MD
Phone
00201017801604
Email
abdelgany2@gmail.com
Facility Information:
Facility Name
Nesreen Abdel Fattah Abdullah Shehata
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nesreen A Shehata, MD
Phone
00201227866337
Email
nesoomar@yahoo.com

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/
Description
Pepene CE. Serum under-carboxylated osteocalcin levels in women with polycystic ovary syndrome: weight-dependent relationships with endocrine and metabolic traits. J Ovarian Res. 2013;6(1):4.

Learn more about this trial

Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women

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