NCT02052479

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

January 29, 2014

Last Update Submit

October 3, 2019

Conditions

Polycystic Ovary SyndromePCOS

Keywords

Polycystic Ovary SyndromePCOSSecondary AmenorrheaHirsutismHyperandrogenismInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Insulin Secretion

    The objective of this study is to examine the differences in insulin secretion between AA and CA adolescents with PCOS. Primary Aim: To determine the influence of racial/ethnic background on insulin secretion in adolescent females with PCOS.

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

Secondary Outcomes (1)

  • Insulin Sensitivity/Resistance

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

Other Outcomes (1)

  • Exploratory Analysis

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

Study Arms (2)

Polycystic Ovary Synrome, PCOS, Caucasian, No treatment

OTHER

Frequently Sampled Intravenous Glucose Tolerance Test with minimal model analysis (MINMOD FSIVGTT)

Other: Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)

Polycystic Ovary Synrome, PCOS, African-American, No treatment

OTHER

Frequently Sampled Intravenous Glucose Tolerance Test with minimal model analysis (MINMOD FSIVGTT)

Other: Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)

Interventions

Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)OTHER
Polycystic Ovary Synrome, PCOS, African-American, No treatmentPolycystic Ovary Synrome, PCOS, Caucasian, No treatment

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center at The Ohio University Wexner Medical Center / Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Links

MeSH Terms

Conditions

Polycystic Ovary SyndromeHirsutismHyperandrogenismInsulin Resistance

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and SymptomsPathological Conditions, Signs and Symptoms46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Endocrinology Fellow

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 3, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 7, 2019

Record last verified: 2019-10

Locations

US(1)