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Home > "M" Clinical Trials Conditions > Metabolic Differences of Overweight Children and Children of Overweight Parents  Metabolic Differences of Overweight Children and Children of Overweight Parents
Metabolic Differences of Overweight Children and Children of Overweight Parents
For Condition: Cardiovascular Disease,Hypertension,Non Insulin Dependent Diabetes Mellitus,Obesity
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: This study focuses on the way weight is gained. Individuals who gain weight primarily in their midsection (visceral weight) are at an increased risk for developing diabetes and high blood pressure. Research has shown that African Americans suffer more often from high blood pressure, diabetes (non-insulin dependent), and heart disease than Caucasian Americans. These conditions lead to significant numbers of deaths and diseases associated with and made worse by obesity. African American women in particular suffer from obesity and the associated conditions of obesity more than any other race or gender. However, it is unknown if the conditions seen in African American women are a result of the obesity or differences in their insulin sensitivity, glucose disposal, or fat metabolism. This study will 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. Patients participating in this study will be followed for 15 years and be evaluated every 5 years during the study.
Details: 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 is 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 related to the greater prevalence of severe obesity among African American women, or due to differences in insulin sensitivity, glucose disposal, or fat cell metabolism. Our studies of normal weight children have found a correlation of the subcutaneous adipose tissue depot with insulin levels before and after an oral glucose tolerance test only in African Americans. It is not known whether these findings are verified with more accurate measures of insulin sensitivity and glucose disposal. It is similarly unknown whether these differences are found in already obese children or in children at high risk for developing obesity. We will 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 will also relate serum levels of the body-fat related circulating factors such as leptin, to these measures, and obtain blood for genomic DNA isolation from participants and their parents to characterize the roles of genes felt important for the development of obesity. We will then follow these children for 15 years, studying them intensively at 5 year intervals until adulthood.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION 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 will have a 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 will have a 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 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 to10 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.
Total Enrollment: 750
Location and Contact Information:
National Institute of Child Health and Human Development (NICHD) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 960101; 96-CH-0101
Study Start Date: June 4, 1996
Record last reviewed: May 29, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001522
Other Non Insulin Dependent Diabetes Mellitus Studies:
1. Prevention of weight gain
2. Physical Activity and Cardiovascular Risk in Black Girls
3. Genomewide Search for Loci Underlying Metabolic Syndrome
4. Energy Expenditure, Diet and Body Fat in Children
5. Comparison of Popular Weight Loss Diets
Related Studies:
Other Non Insulin Dependent Diabetes Mellitus Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Metabolic Differences of Overweight Children and Children of Overweight Parents
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