TerminatedNot Applicable

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

United States12 participantsStarted 2014-01

Plain-language summary

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.

Who can participate

Age range12 Years – 18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Insulin Secretion

Timeframe: -10, 0, 2, 4, 6, 8, 12, 14, 16, 19, 22, 27, 32, 42, 52, 62, 72, 82, and 92 minutes

Trial details

NCT IDNCT02052479

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06