Effect of Bromocriptine on Insulin Resistance in Polycystic Ovarian Syndrome - A Pilot Study

NCT02133755 | Unknown Phase 3

• 1 other identifier: PCOS-Pilot
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to determine the effect of dopamine agonist therapy on insulin resistance in lean vs. obese women with polycystic ovary syndrome. Polycystic ovary syndrome (PCOS) is a common metabolic abnormality in women. The diagnosis of PCOS relies on a constellation of symptoms and signs (problems with ovulation, clinical and/or biochemical signs of hyperandrogenism and cystic ovaries). Though not a diagnostic feature, insulin resistance (IR) is a hallmark of PCOS and up to 80% women with PCOS have IR. Although IR is more significant in obese women with PCOS, even lean women can be insulin resistant. No current therapy addresses the problem of insulin resistance in PCOS. Studies have suggested a dopamine deficiency in patients with PCOS, which may underlie the insulin resistance and may have a pathogenetic role in the development of PCOS. No study to date has assessed the impact of dopamine agonist therapy on IR in patients with PCOS.

Conditions

PCOS; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Insulin Resistance (IR)

  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.

  3 months

Secondary Outcomes (1)

• IR based on BMI

  3 months

Study Arms (1)

Bromocriptine mesylate (Cycloset)

OTHER

Cycloset 1.6 to 3.2 mg daily for 3 months

Drug: Bromocriptine

Interventions

Bromocriptine DRUG

Three month administration of bromocriptine. Baseline ultrasound and laboratory parameters measured. Repeat measures at discontinuation of drug at 3 months.

Also known as: Cycloset

Bromocriptine mesylate (Cycloset)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women age 18 to 45 years with PCOS willing to maintain consistent weight for 3 month study period

You may not qualify if:

• diabetes other conditions associated with insulin resistance previous intolerance to dopamine agonist therapy concomitant medication that would interfere with dopamine agonist therapy insulin resistance syndrome type A or Type B

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ali Imran, MD, FRCPC

  QE II Health Science Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 8, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

CA (1)