Clinical trial NCT00001195: Endocrine Studies of Healthy Children
Official title: Endocrine Studies of Healthy Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Development
Hormones
Growth
Metabolism
Eating Behavior
Body Composition
Normal Volunteer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 1247
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: Researchers would like to determine normal ranges for hormone levels and to learn more about the genetics involved in hormone production and action. Researchers will take samples of blood, urine, saliva, and stool from healthy children ages 5-17 in order to study different aspects of hormones.

Establishing a range of normal hormone levels in children will make diagnosing illnesses with abnormal levels of hormones much easier. Hormone levels in the body can change throughout the day. By collecting samples at different times researchers hope to learn more about the normal daytime and nighttime patterns of hormone secretion. Because some hormone levels change with body size, researchers will also take measurements of patient's body composition.

This study will involve children and observe them as inpatients or as outpatients. \<TAB\>

Detailed description: We wish to obtain blood, urine, saliva, and stool specimens from healthy children ages 2-18 years for use in establishing the normal ranges of levels of hormones and the variations in genes that are important for hormones to act. Such hormone values are extremely important to allow endocrinologists to determine when hormone levels are truly abnormal in children suspected of an illness. Because the values of some hormones change with body size, we will obtain measurements of body composition when studying such hormones. Children participating in this study may be studied in the outpatient clinic (at most 2 blood draws) or as inpatients on the pediatric ward (for frequent blood sampling using an intravenous line over a 24-hour period). Other studies that may be performed as part of this study include ultrasound examinations of the thyroid, adrenal, ovaries or testes, and x-ray of the hand and wrist for bone age determination.

Eligibility criteria: * INCLUSION CRITERIA:

Good general health.

Age 2 to 18 years.

EXCLUSION CRITERIA:

Volunteers will be excluded for the following reasons:

Presence of renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing's syndrome) or pulmonary disorders (other than asthma not requiring continuous medication);

Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study;

Subjects who regularly use prescription medications are not eligible. The use of over-the-counter medications will be reviewed on a case-by-case basis;

For those sub-studies involving MRI, inability to undergo MRI (e.g., volunteers with metal within their bodies including cardiac pacemakers, neural pacemakers, aneurysmal clips, shrapnel, ocular foreign bodies, cochlear implants, non-detachable electronic or electromechanical devices such as infusion pumps, nerve stimulators, bone growth stimulators, etc. that are contraindications).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Jack A Yanovski, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nisula BC, Loriaux DL, Wilson YA. Solid phase method for measurement of the binding capacity of testosterone-estradiol binding globulin in human serum. Steroids. 1978 May;31(5):681-90. doi: 10.1016/s0039-128x(78)80008-7. No abstract available.
citation: Nisula BC, Dunn JF. Measurement of the testosterone binding parameters for both testosterone-estradiol binding globulin and albumin in individual serum samples. Steroids. 1979 Dec;34(7):771-91. doi: 10.1016/0039-128x(79)90090-4.
citation: Wehmann RE, Rubenstein HA, Nisula BC. A sensitive, convenient radioimmunoassay procedure which demonstrates that serum hTSH is suppressed below the normal range in thyrotoxic patients. Endocr Res Commun. 1979;6(3):249-55. doi: 10.3109/07435807909061799.
citation: Han JC, Reyes-Capo DP, Liu CY, Reynolds JC, Turkbey E, Turkbey IB, Bryant J, Marshall JD, Naggert JK, Gahl WA, Yanovski JA, Gunay-Aygun M. Comprehensive Endocrine-Metabolic Evaluation of Patients With Alstrom Syndrome Compared With BMI-Matched Controls. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2707-2719. doi: 10.1210/jc.2018-00496.
citation: Radin RM, Tanofsky-Kraff M, Shomaker LB, Kelly NR, Pickworth CK, Shank LM, Altschul AM, Brady SM, Demidowich AP, Yanovski SZ, Hubbard VS, Yanovski JA. Metabolic characteristics of youth with loss of control eating. Eat Behav. 2015 Dec;19:86-9. doi: 10.1016/j.eatbeh.2015.07.002. Epub 2015 Jul 18.
citation: Tanofsky-Kraff M, Shomaker LB, Stern EA, Miller R, Sebring N, Dellavalle D, Yanovski SZ, Hubbard VS, Yanovski JA. Children's binge eating and development of metabolic syndrome. Int J Obes (Lond). 2012 Jul;36(7):956-62. doi: 10.1038/ijo.2011.259. Epub 2012 Jan 10.