Effect of Bromocriptine on Insulin Resistance in Polycystic Ovarian Syndrome - A Pilot Study (PCOS-Pilot)
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|ClinicalTrials.gov Identifier: NCT02133755|
Recruitment Status : Unknown
Verified May 2014 by Cora fanning, IWK Health Centre.
Recruitment status was: Not yet recruiting
First Posted : May 8, 2014
Last Update Posted : May 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|PCOS Insulin Resistance||Drug: Bromocriptine||Phase 3|
Does bromocriptine improve measures of insulin resistance in females with polycystic ovarian syndrome and is there a differential benefit based on Body Mass Index (BMI, kg/m2).
This study will use a single subject design where patients with PCOS will have regular clinical laboratory tests before and after treatment with bromocriptine. It is a pilot study comprised of 20 women with normal BMI (<25) and 40 women with BMI ≥27.
Study data will be collected from participants during regularly scheduled clinic visits (enrolment) and 3 months later (follow-up). Standard care examinations, blood work and pelvic ultrasound will be performed and included as the study data.
The main outcome of interest will be to evaluate the change in HOMA-IR (Homeostatic Model Assessment - Insulin Resistance) from baseline. It is calculated using a fasting glucose and insulin level. Additionally, to determine the magnitude of effect on HOMA-IR as a measure of insulin sensitivity in lean compared to obese women and the effect on insulin sensitivity in those with and without insulin resistance.
Other measure of interest will be a change in glycated hemoglobin (A1C), serum androgens and pituitary hormone levels. No additional tests will be obtained above what is done in the course of usual assessment of patients with PCOS
Change in HOMA-IR values will be calculated for each individual patient and tested using a paired t-test to determine if therapy had a significant impact on HOMA-IR values. A multivariate linear regression will then be applied to determine if this change in HOMA-IR values was influenced by either BMI or baseline HOMA-IR value along with any other potentially confounding variables.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Bromocriptine on Insulin Resistance in Polycystic Ovarian Syndrome - A Pilot Study|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2015|
Bromocriptine mesylate (Cycloset)
Cycloset 1.6 to 3.2 mg daily for 3 months
Three month administration of bromocriptine. Baseline ultrasound and laboratory parameters measured. Repeat measures at discontinuation of drug at 3 months.
Other Name: Cycloset
- Insulin Resistance (IR) [ Time Frame: 3 months ]Will bromocriptine improve measures of IR in females with PCOS? IR is a reduced glucose response for given concentration of insulin. IR can be estimated from fasting glucose and insulin levels using the Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) equation: HOMA-IR = fasting plasma glucose (mmol/L) x fasting serum insulin (μU/mL) / 22.5. HOMA-IR correlates well with estimates using the euglycemic clamp method (r = 0.88). A recent study of healthy, young, insulin sensitive, Canadian subjects found that HOMA IR values were 0.78 for Caucasians, 0.82 for East Asians and 1.08 for South Asians. While this demonstrates some ethnic variability, the values for insulin sensitive individuals are lower than traditional cut-off values. With this in mind, and an understanding of the inherent limitations of HOMA-IR, we have chosen a cut-off value of 2, above which we will define insulin resistance and below which, patients will be considered to be insulin sensitive.
- IR based on BMI [ Time Frame: 3 months ]Is there a differential benefit in insulin resistance reduction based on Body Mass Index (BMI, kg/m2)?
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): NCT02133755
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Contact: Renda Bouzayen, MD, FRCSC 902-470-6457 email@example.com|
|Contact: Cora Fanning, BN 902-470-7158 firstname.lastname@example.org|
|Principal Investigator: Renda Bouzayen, MD, FRCSC|
|Principal Investigator:||Ali Imran, MD, FRCPC||QE II Health Science Centre|