A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

Observacional

Fase

No aplica / no indicada

Rango de edad

5 años - 12 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

400 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

Background:

Obesity affects 1 in 5 children in the United States. Childhood obesity often persists into adolescence and adulthood. It can also raise the risk of sleep apnea, fatty liver disease, and fluid buildup in the brain and lead to early-onset puberty. This natural history study will explore how factors such as genes, hormones, diet, and chemical exposures affect puberty in children with obesity.

Objective:

To learn which factors predict the early start of puberty in children with obesity vs those of normal weight.

Eligibility:

Children aged 5 to 7 years with obesity or of normal weight.

Design:

Participants will have clinic visits every 6 months until they reach age 12.

Each clinic visit will include these tests and procedures:

A physical exam.

Collection of blood, urine, and saliva samples. Some samples will be used for genetic tests.

Questions about medical history and medications and supplements.

A questionnaire about their physical activity over the previous week.

A silicone wrist band. Participants will wear a soft wristband for a week prior to each visit. It will tell researchers what chemicals the children were exposed to during that time.

Breast ultrasound, for girls. A gel will be applied, and a wand will be pressed against the skin. The wand uses sound waves to see the tissue inside the breast.

DXA whole body scan. Once a year, participants will have a DXA (dual energy X-ray absorptiometry) scan. This scan measures the amount of bone, muscle, and fat in the body.

Optional food diary. Parents may record everything the participant eats for two 24-hour periods

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¿Quién podría participar?

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• INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Stated willingness to comply with all study procedures and availability for the duration of the study, including sharing medical records
2. Male or female, aged 5 to 7 years at the screening visit
3. Normal weight (defined as BMI \> 5th percentile and \<85th percentile for age and sex) or Obese weight (defined as BMI \> 95th percentile for age and sex)
4. Ability of parent or guardian to understand and willingness to sign a written informed consent document. And ability of the participant (child) to provide verbal assent and/or to sign a written assent document.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Known diagnosis of syndromic/genetic form of obesity
2. Current use of medications or supplements that affect reproductive hormones (e.g., estrogen, progesterone, testosterone, puberty blockers, regular use of lavender oil or tea tree oil)
3. Chronic medical conditions (e.g., type 1 or type 2 diabetes, cancer, renal failure, lupus, etc.), at the discretion of the Principal Investigator
4. Clinically significant abnormal laboratory values, at the discretion of the Principal Investigator
5. International adoptee (associated with earlier puberty)

Individuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.

Población del estudio

Children from the community and the Obesity Weight Management Clinic within the greater Raleigh, Durham, Chapell Hill North Carolina area.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No informado

Enmascaramiento

No informado

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (1)

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1 centros

Equipo y fechas

Patrocinador principal

National Institute of Environmental Health Sciences (NIEHS)

Inicio del estudio

15 nov 2026 Estimado

Finalización primaria

23 dic 2036 Estimado

Finalización del estudio

23 dic 2036 Estimado

Primera publicación

27 feb 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio