Completed

Population Differences in the Insulin Sensitivity, Resting Energy Expenditure, and Body Composition of Overweight Children and Children of Overweight Parents

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Body Weight+9

+ Hyperinsulinism

+ Metabolic Diseases

Over 6 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 1996
See protocol details

Summary

Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: September 23, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: June 6, 1996

Actual date on which the first participant was enrolled.

African Americans have a greater prevalence than Caucasian Americans of hypertension, non-insulin-dependent diabetes mellitus, and cardiovascular disease. These conditions lead to substantial excess morbidity and mortality and are associated with and exacerbated by obesity, the prevalence of which is strikingly elevated in African American women. It is unknown if this increased prevalence of comorbid conditions is solely related to the greater prevalence of severe obesity among African American women, or due to differences in insulin sensitivity, glucose disposal, body composition, or fat cell metabolism. Through this project, we have verified that many of the physiological differences observed between African American and Caucasian adults are already present in obese children and in children at high risk for developing obesity. However, the roles that differences in energy expenditure, glucose metabolism, body composition, and other factors play in determining which children develop obesity and its comorbid conditions in adulthood remain unclear. In this study, we compare body composition, total and resting energy expenditure, and glucose disposal of obese African American and Caucasian children and of non-obese children of obese African American and Caucasian parents, to characterize the timing and nature of factors that may contribute to the prevalence of obesity and its complications. We also relate serum levels of the body-fat related circulating factors such as leptin, to these measures, and obtain samples for genomic DNA isolation from participants and their parents to characterize the roles of genes felt important for the development of obesity. We will follow these children for 15 years, studying them intensively at 5 year intervals until adulthood.

NCT00001522
Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: September 23, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

246 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 6 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightHyperinsulinismMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweightInsulin ResistanceObesity

Criteria

INCLUSION CRITERIA: Volunteers will qualify for inclusion under this protocol if they meet the following criteria: Good general health. Individuals with renal, hepatic, most endocrinologic (e.g. hypothyroidism, or Cushing syndrome), or pulmonary disorders (other than mild asthma not requiring chronic medication) will be excluded. For obese subjects, body mass index for age above the 85th percentile (determined by NHANES I age-, sex-, and race-special data). For normal weight subjects of obese parents, body mass index (determined by NHANES I age-, sex-, and race- specific data) between the 5th and 85th percentile and both parents' current body mass index above 25 kg/m(2), or a history of a body mass index above 25 kg/m(2). No significant psychiatric illness. At initial visit, Tanner I (prepubertal) or Tanner II (early pubertal) pubic hair and breast stage of development for girls, and Tanner I or Tanner II pubic hair and testes size (6ml) for boys. Subjects must be able to undergo MRI. Volunteers with metal in their bodies that are contraindications for MRI will be excluded. These include 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.). Age 6 to12 years at the start of the study. For girls who have been followed to an age when they are menstruating (or are of an age when pregnancy is a possibility), a negative pregnancy test. Race of all 4 grandparents self-identified either as all Caucasian or all African American.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center