Polycystic Ovarian SyndromePhase 1U-C OC IN PCOSNCT02244567
Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women
A Phase 1 study testing Metformin 850 mg twice daily for 3 months, Serum uc-oc and drug in people with Polycystic Ovarian Syndrome, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome
- What is being tested?
- Metformin 850 mg twice daily for 3 months, Serum uc-oc and drug
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2014to Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Lean women BMI 25 or less
- Hyperandrogenic clinically and/or biochemically.
- Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria
Who cannot join
- BMI more than 20
- Other causes of hyperandrogenism
- Other causes of metabolic disorders or diabetes.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nesreen Abdel Fattah Abdullah Shehata
Cairo
Nesreen A Shehata, MD, 00201227866337, nesoomar@yahoo.com
About this study
Official title: Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin in Hyperandrogenic Lean PCOS Women
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.
Read the 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).
- Conditions
- Polycystic Ovarian Syndrome
- Being tested
- Metformin 850 mg twice daily for 3 months, Serum uc-oc, drug
- Keywords
- PCOS
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 850 mg twice daily for 3 monthsDrug
Also called Cidophage
This drug is insulin sensitizing agent which will be given twice daily orally for 3 months for PCOS patients.
Serum uc-ocProcedure or surgery
Also called Serum undercarboxylated-osteocalcin
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.
drugOther
Also called vitamin
This group of patients will receive any type of vitamin as a placebo to compare with effect of Metformin on serum UC-OC.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Cidophage 850 mg twice daily for three months will be given to the patientwith PCOS. Receives: Drug: Metformin 850 mg twice daily for 3 months |
| Serum under-carboxylated osteocalcin | Active comparator | Serum uc-oc will be measured before and after 3 months of treatment with cidophage. Receives: Procedure: Serum uc-oc |
| Placebo | Active comparator | Other group of patients with high serum UC-OC will be given a placebo. Receives: Other: drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244567
- Sponsor's protocol ID
- Beni-Suef 4
- Acronym
- U-C OC IN PCOS
- Status last verified
- Jan 2021
- First submitted
- 13 Sep 2014
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin in Hyperandrogenic Lean PCOS Women
- ClinicalTrials.gov ID
- NCT02244567
- Acronym / sponsor ID
- U-C OC IN PCOS / Beni-Suef 4
- Conditions
- Polycystic Ovarian Syndrome
- Keywords
- PCOS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Sep 2014
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin 850 mg twice daily for 3 monthsCidophage 850 mg twice daily for three months will be given to the patientwith PCOS. |
| Serum under-carboxylated osteocalcin | Active comparator | Procedure: Serum uc-ocSerum uc-oc will be measured before and after 3 months of treatment with cidophage. |
| Placebo | Active comparator | Other: drugOther group of patients with high serum UC-OC will be given a placebo. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Lean women BMI 25 or less
- Hyperandrogenic clinically and/or biochemically.
- Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria
Key exclusion criteria (3 listed)
- BMI more than 20
- Other causes of hyperandrogenism
- Other causes of metabolic disorders or diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin 850 mg twice daily for 3 monthsAlso: CidophageThis drug is insulin sensitizing agent which will be given twice daily orally for 3 months for PCOS patients. | Drug | Metformin |
| Serum uc-ocAlso: Serum undercarboxylated-osteocalcinSerum 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. | Procedure or surgery | Serum under-carboxylated osteocalcin |
| drugAlso: vitaminThis group of patients will receive any type of vitamin as a placebo to compare with effect of Metformin on serum UC-OC. | Other | Placebo |
Primary outcome
High Serum under-carboxylated osteocalcin
Time frame: 3 months
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.
1 secondary outcome
Metformin therapy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin 850 mg twice daily for 3 months, Serum uc-oc and drug in people with Polycystic Ovarian Syndrome, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nesreen A Shehata, MD (00201227866337, nesoomar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Serum under-carboxylated osteocalcin (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.