Insulin Differences Between African-American and Caucasian Female Adolescents With Polycystic Ovary Syndrome (PCOS)

Stopped early · Not applicable

Conditions studied: Polycystic Ovary Syndrome, PCOS

In brief

The purpose of this research study is to see if there are differences between African-American and Caucasian girls with Polycystic Ovary Syndrome (PCOS) in how their bodies respond to a type of sugar, called glucose, the body's main source of energy. PCOS is one of the most common endocrine disorders among females. Features can include anovulation (eggs are not released from the ovaries) resulting in irregular menstrual periods, excessive amounts of androgenic (male) hormones resulting in acne and hirsutism (excessive hair growth on the face and body), and polycystic ovaries (small sac-like structures \[cysts\] on your ovaries) seen on ultrasound. Girls with PCOS also have higher levels of insulin in their bodies (called hyperinsulinism) but are not able to use insulin very well (called insulin resistance) resulting in an increased risk of diabetes. Diabetes is when you have high levels of glucose (sugar) in your blood. Many studies have looked at how bodies respond to glucose and have shown that compared to Caucasians, healthy African-Americans produce much more insulin (hyperinsulinism) but are not able to use it as well (insulin resistance) in childhood, adolescence, and adulthood. Insulin is a hormone that helps glucose move from the blood into the muscles for the body to use as energy. PCOS is associated with increased levels of insulin (hyperinsulinism) and not being able to use it as well (insulin resistance). So we want to see if there is a difference in insulin production (secretion) and insulin resistance between African-Americans and Caucasians girls with PCOS. To do this, we will look at blood glucose and insulin levels in response to giving glucose in African-American and Caucasian girls who have PCOS. The results of this study may ultimately help to more effectively target treatment therapy in individuals with PCOS that have increased insulin secretion and/or increased insulin resistance.

Key facts

Study ID

NCT02052479

Run by

Nationwide Children's Hospital

People needed

12

Starts

2014-01-01

Expected to finish

2015-06-01

Last updated by the study team

2019-10-07

Who can join

Age: 12 and older, up to 18. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Children and adolescents ages 12-18 years
• African-American and Caucasian females
• Menarchal for at least 2 years
• Hemoglobin A1C <6.5%
• Medical Condition: Polycystic Ovary Syndrome (PCOS) - based on AES criteria: HA in addition to ANOV and/or PCO
• Hyperandrogenism (required): Serum Testosterone > 50 ng/dl or Free Testosterone (%) > 1.4% or Free Testosterone > 7 pg/mL
• Oligo- and/or Anovulation: menstrual cycles lengths > 35 days and/or < 8 menstrual cycles a year
• Polycystic Ovaries: transabdominal or trans-vaginal ultrasound finding of 12 or more follicles measuring 2-6 mm in diameter or increased ovarian volume (> 10 mL)
• Medications: Medication-naive to treatment therapy with Metformin, Oral Contraceptives, and Anti-androgen medications

You may not qualify if…

• Ages <12 or >18
• Prepubertal, Premenarche
• Hemoglobin A1C ≥6.5%
• Medical Conditions: Hypothyroidism, Hyperthyroidism, Diabetes Mellitus, Congenital Adrenal Hyperplasia, Hyperprolactinemia, Pregnancy
• Medications: Past and/or Present treatment therapy with Metformin, Oral Contraceptives, Anti-androgen medications, Insulin or oral hypoglycemic agents

Where it is running

• Clinical Research Center at The Ohio University Wexner Medical Center / Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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