PCOSNCT00683774
Insulin and Polycystic Ovary Syndrome
A study testing diazoxide in people with PCOS, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS
- What is being tested?
- diazoxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obese women with PCOS and normal women aged 18-40,
- PCOS less than 8 periods/year, elevated total or free testosterone, normal thyroid function tests and serum prolactin, exclusion of adrenal hyperplasia
- Normal regular monthly periods, no clinical evidence of androgen excess,
- All Acceptable health on interview, medical history, physical exams and lab tests, signed, witnessed informed consent and ability to comply to study requirements
Who cannot join
- DM, clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic or malignant disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center
Richmond, Virginia, 23298
About this study
Official title: Determination if Direct Inhibition of Insulin Release With Diazoxide Decreases Renal Clearance of D-Chiroinositol (DCI) and Increases Circulating DCI in Obese Women With Polycystic Ovary Syndrome (PCOS)
Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with PCOS 1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.
- Conditions
- PCOS
- Being tested
- diazoxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diazoxideDrug
100mg orally three times per day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| PCOS subjects | Experimental | PCOS subjects given diazoxide Receives: Drug: diazoxide |
| Normal subjects | Active comparator | Normal subjects given diazoxide Receives: Drug: diazoxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Clearance of D-chiroinositol (DCI) at 12 Days
Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay
Measured: 12 days
Level of Circulating D-chiro Inositol (DCI)
Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startNov 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- John E. Nestler, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683774
- Sponsor's protocol ID
- VCU IRB 4479
- Other IDs
- 2R01HD035629-09A2
- Status last verified
- Jun 2017
- First submitted
- 21 May 2008
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination if Direct Inhibition of Insulin Release With Diazoxide Decreases Renal Clearance of D-Chiroinositol (DCI) and Increases Circulating DCI in Obese Women With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT00683774
- Acronym / sponsor ID
- VCU IRB 4479
- Conditions
- PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Posted 21 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with PCOS 1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS subjects | Experimental | Drug: diazoxidePCOS subjects given diazoxide |
| Normal subjects | Active comparator | Drug: diazoxideNormal subjects given diazoxide |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Obese women with PCOS and normal women aged 18-40,
- PCOS less than 8 periods/year, elevated total or free testosterone, normal thyroid function tests and serum prolactin, exclusion of adrenal hyperplasia
- Normal regular monthly periods, no clinical evidence of androgen excess,
- All Acceptable health on interview, medical history, physical exams and lab tests, signed, witnessed informed consent and ability to comply to study requirements
Key exclusion criteria (1 listed)
- DM, clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic or malignant disease.
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 |
|---|---|---|
| diazoxide100mg orally three times per day for 10 days | Drug | Normal subjects, PCOS subjects |
Primary outcome
Renal Clearance of D-chiroinositol (DCI) at 12 Days
Time frame: 12 days
Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay
Level of Circulating D-chiro Inositol (DCI)
Time frame: 12 days
Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink 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.
John E. Nestler, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diazoxide in people with PCOS, run by Virginia Commonwealth University at 1 site in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jun 2017. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Clearance of D-chiroinositol (DCI) at 12 Days (time frame: 12 days). The study lists 2 primary outcomes in all. 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 14 Jun 2017.