Role of Novel Androgens in Premature Adrenarche

Study ID
STU 082012-004

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas

Contact
Joshua Smith
214-456-8629
joshua.smith@utsouthwestern.edu

Principal Investigator
Joshua Smith

Summary

Study Design
This is a physician-initiated study. To fulfill the study aims, we will recruit children referred to our pediatric endocrine practice at Children[Right Quote]s Medical Center in Dallas, TX. The recruitment goals for these subjects are outlined in figure 3 (recruitment of children with premature adrenarche) and figure 4 (recruitment of normal children). Our control subjects will consist of children referred and seen in the pediatric endocrine clinic with congenital hypothyroidism who have normal thyroid function studies. These children have their thyroid studies performed routinely and should be otherwise normal. Their thyroid studies are blood tests and are part of the standard of care. We will also recruit patients from the Center for Obesity And its Consequences to Health (COACH) clinic. These patients have labs performed periodically as standard of care. They will be eligible to participate as normal subjects as long as they have no thyroid dysfunction, late-onset adrenal hyperplasia, insulin resistance, diabetes mellitus, or medication affecting adrenal, gonadal, or carbohydrate or lipid metabolism. The work up of patients with premature adrenache involves blood work and the extra labs that we will be collecting will not necessitate extra phlebotomy. Samples will be obtained as part of the routine evaluation.

If patients are not having labs performed as standard of care at CMC or already had labs performed prior to the clinic visit, then I will still attempt to recruit them but they will require compensation for their participation in the study. This is due to the fact that the child will have labs drawn outside of the scheduled standard of care labs. The compensation for this effort will be a $25 voucher than can be redeemed for cash at Children[AND]amp;apos;s Medical Center.

Procedures
The medical history, physical exam, and phlebotomy to obtain a blood sample are necessary to complete the research proposal. All these procedures will be preformed regardless on our subjects as part of necessary diagnosis and/or treatment of subjects. For subjects in Aims 1 and 2, we will obtain blood (5 mL), a medical history and physical exam at one time. The blood will be processed and the patient information de-identified. The sample will then be sent to a research lab in Michigan, where the analysis for our novel androgens will occur. If lab work is performed at a time outside of the standard of care labs, then we will compensate the subject for their participation.

Participant Eligibility

Study Patients: Patients referred for premature pubarche (pubic hair first noted in <8 year girls, or <9 year boys) without thyroid dysfunction, diabetes mellitus or insulin resistance, or medications affecting adrenal, gonadal, or carbohydrate or lipid metabolism.

Normal Subjects: Patients age 2-10 years referred for evaluation for congenital hypothyroidism but have normal TSH levels,or obese patients from the COACH clinic and do not have any of the following: thyroid dysfunction, late-onset adrenal hyperplasia, insulin resistance, diabetes mellitus, or medication affecting adrenal, gonadal, or carbohydrate or lipid metabolism