Metabolic and Hormonal Changes Induced by Pioglitazone in Polycystic Ovary Syndrome: A Randomized, Placebo-Controlled Clinical Trial
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CONTEXT: Polycystic ovary syndrome (PCOS) is characterized by insulin resistance, compensatory hyperinsulinemia, increased prevalence of impaired glucose tolerance, and increased ovarian androgen biosynthesis. OBJECTIVE: The aim of the study was to evaluate effects of pioglitazone on whole body insulin action and ovarian androgen biosynthesis in PCOS. DESIGN: We performed a randomized placebo-controlled trial. SETTING: The study was conducted at the Special Diagnostic and Treatment Unit of the Veterans Affairs Medical Center, San Diego, and the University of California, San Diego, General Clinical Research Center. PATIENTS OR OTHER PARTICIPANTS: A total of 23 subjects with PCOS were evaluated at baseline and end of treatment. Six age- and body mass index-matched women without PCOS were normal controls for baseline evaluation. INTERVENTION: Subjects with PCOS were randomized to oral placebo or pioglitazone 45 mg daily for 6 months. MAIN OUTCOME MEASURE(S): The primary outcome measures were whole body insulin action as measured by hyperinsulinemic euglycemic clamp and ovarian androgen biosynthesis as measured by leuprolide-stimulated production of 17-hydroxyprogesterone (17-OHP). RESULTS: Compared with placebo, pioglitazone treatment significantly improved multiple measures of insulin action, including glucose disposal rate (P < 0.01), 2-h glucose during 75-g oral glucose tolerance test (P < 0.01), area under the curve glucose during oral glucose tolerance test (P < 0.01), serum adiponectin (P < 0.01), and fasting hyperinsulinemia (P < 0.01). Compared to placebo, pioglitazone treatment reduced the increment of leuprolide-stimulated 17-OHP (P < 0.02). Improvements in glucose disposal rate correlated with reductions in 17-OHP stimulation (P < 0.02). CONCLUSIONS: Compared to placebo, pioglitazone treatment in PCOS was associated with improvements in insulin action and glucose homeostasis and ameliorated the hyperandrogenic ovarian response.
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In the study by Aroda and colleagues, in the pioglitazone arm, 40% of patients with altered oral glucose tolerance test reverted to normality and no one experienced a worsening of their glucose tolerance status.
“Meanwhile, in the pioglitazone arm, 40% of patients with altered OGTT reverted to normality and no one has experienced a worsening of their glucose tolerance status.”
From From Prediabetes to Type 2 Diabetes Mellitus in Women with Polycystic Ovary Syndrome: Lifestyle and Pharmacological Management (2020) · cites this paper as [65]
In the study by Aroda and colleagues, in the placebo group, 29% of patients with normal oral glucose tolerance test had an impaired glucose response at the end of the observation period, whereas none of the patients with impaired glucose tolerance response reverted to normality.
“Furthermore, in the placebo group, 29% of the patients with normal OGTT had an impaired glucose response at the end of the observation period, whereas none of the patients with impaired glucose tolerance response reverted to the normality.”
From From Prediabetes to Type 2 Diabetes Mellitus in Women with Polycystic Ovary Syndrome: Lifestyle and Pharmacological Management (2020) · cites this paper as [65]
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- Authors
- Aroda, V. R., Ciaraldi, T. P., Burke, P., Mudaliar, S., Clopton, P., Phillips, S., Chang, R. J., & Henry, R. R.
- Affiliations
- University of California San Diego (US)
- VA San Diego Healthcare System (US)
- Corresponding author
- Aroda, Vanita R.
- ORCID
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2009-02-01
- Volume
- 94
- Issue
- 2
- Pages
- 469-476
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- PMC
- PMC2646515
- OpenAlex
- W1993147498
- Cited by
- 71
- References
- 37
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 1 · 2023: 2 · 2022: 5 · 2021: 4 · 2020: 4 · 2018: 2 · 2017: 3 · 2016: 2 · 2015: 7 · 2014: 5 · 2013: 7 · 2012: 7
- FWCI
- 7.27
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Veterans Affairs
- National Center for Research Resources (M01RR000827)
- NIH Clinical Center
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (P50HD012303, U54HD012303)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetic and Kidney Cyst Diseases
- Keywords
- pioglitazone, polycystic ovary syndrome, insulin resistance, insulin action, glucose homeostasis, 17-hydroxyprogesterone, adiponectin, hyperinsulinemia, glucose disposal rate, thiazolidinediones
- MeSH terms
- Pioglitazone, Adult, Blood Glucose, Female, Glucose Tolerance Test, Humans, Hypoglycemic Agents, Insulin, Placebos, Polycystic Ovary Syndrome, Gonadal Steroid Hormones, Glucose Intolerance, Thiazolidinediones
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