Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation

NCT01421797 | Unknown

• 3 other identifiers: 12702JCM022U54HD028934-18
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much facial and body hair, and weight gain. Women with PCOS also have a hard time becoming pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as adults. Some girls with high levels of male hormone will develop normal hormone levels as they grow up, but most girls continue to have high levels of male hormone as adults. The purpose of this study is to understand where the male and female hormones come from in girls as they get older. The investigators think the adrenal gland, makes most of the hormones in young girls and that the ovary and the adrenal gland make these hormones in older girls. The investigators would like to find out whether an overactive adrenal gland makes these hormones higher in girls who are overweight, compared to those who are not overweight.

Conditions

Hyperandrogenemia; Polycystic Ovary Syndrome; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.

  A primary endpoint for analysis in this study is the change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.

  Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning).

Secondary Outcomes (2)

• Overnight changes in male and female hormones in response to ACTH suppression

  14 hours (Sampling begins at 1900 hours and proceeds through 0800 the following morning)

• Response to ACTH stimulation in normal weight and overweight girls

  14 hours (1900 - 0800 hrs)

Study Arms (1)

Dexamethasone, Cortrosyn

EXPERIMENTAL

Dexamethasone given 1 mg PO Cortrosyn given single IV bolus 0f 0.25 mg

Drug: Dexamethasone; Drug: Cortrosyn

Interventions

Dexamethasone DRUG

1 mg PO

Dexamethasone, Cortrosyn

Cortrosyn DRUG

single IV bolus of 0.25 mg will be administered

Also known as: ACTH

Dexamethasone, Cortrosyn

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Normal and obese (\>95th BMI%) females
• Weight of 24 kg or more
• Early to late puberty (expected age range 7-18)
• Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)

You may not qualify if:

• Screening labs outside of age-appropriate normal range
• Hemoglobin \<12 mg/dL and hematocrit\<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still \<36%, they will be excluded.)
• Morning Cortisol \<5 g/dL
• hydroxyprogesterone \>295 ng/dL
• Weight\<24 kg
• History of Cushing's syndrome or adrenal insufficiency
• Pregnant (self reported)

Sponsors & Collaborators

• University of Virginia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of California, San Diego: collaborator

Study Sites (1)

University of Virginia Center for Research in Reproduction

Charlottesville, Virginia, 22902, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity

Interventions

Dexamethasone; Cosyntropin; Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Christine Burt Solorzano, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 23, 2011
• Study Start: October 10, 2006
• Primary Completion: August 27, 2024
• Study Completion: December 1, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

US (1)