Status:
TERMINATED
Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Obesity
Short Stature
Eligibility:
All Genders
7-14 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: \- Overweight and obese children and adults often have lower levels of growth hormone in the blood. Regulation of growth hormone may be tied to weight and free fatty acids in the blood. C...
Detailed Description
Obese children and adults display lower spontaneous and stimulated growth hormone (GH) secretion. It is presumed that dysregulation of some of the factors normally involved in controlling GH secretion...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects will qualify for the overweight group for the dose-establishing studies 1 and 2 and main study) if they meet the following criteria:
- Good general health.
- Age greater than or equal to 7 and less than 15 years.
- Tanner stage I, II or III for the breast among girls and testes less than10 mL for boys based upon an examination by a trained physician or nurse practitioner.
- Weight \> 30 kg.
- Fasting plasma glucose \< 100 mg/dL, 2 hour post-dextrose glucose \< 140 mg/dL, and HgbA1C less than or equal to 6.4%.
- Females who are age 10 or greater must have a negative pregnancy test.
- Body mass index greater than or eqaul to 95th percentile determined by Centers for Disease Control age and sex specific data (given that most pathology of obesity does not usually emerge until children cross the 95th percentile).
- No evidence of growth failure as defined as height \> 5th percentile.
- Subjects will qualify for the non-overweight control group (for the main study only) if they meet the following criteria:
- Recommended by a pediatric endocrinologist to undergo GH stimulation testing to establish the diagnosis of GH-deficiency.
- Good general health.
- Age greater than or equal to 7 and less than15 years.
- Tanner stage I, II or III for the breast among girls and testes less than 10 mL for boys based upon an examination by a trained physician or nurse practitioner.
- Weight \> 30 kg.
- Fasting plasma glucose \< 100 mg/dL, 2 hour post-dextrose glucose \< 140 mg/dL, and HgbA1C less than or equal to 6.4%.
- Females who are age 10 or greater must have a negative pregnancy test.
- Height \< 5th percentile.
- BMI between the 5th and 85th percentiles determined by Centers for Disease Control age and sex specific data.
- Birth weight and length not consistent with small for gestational age (SGA) criteria or a history of intrauterine growth restriction (IUGR) based on recall history.
- EXCLUSION CRITERIA (for the dose-establishing sutides 1 and 2, and the main study):
- Subjects will be excluded if they have any of the following:
- Baseline creatinine greater than or equal to 1.0 mg/dl.
- Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion.
- Hepatic disease with elevated liver function tests (ALT or AST)greater than or equal to 1.5 the upper limits of normal.
- Pregnancy.
- Evidence for impaired glucose tolerance or Type 2 diabetes, including fasting plasma glucose greater than or equal to 100 mg/dL, 2 hour post-dextrose glucose greater than or equal to 140 mg/dL, or HgbA1C \> 6.4%.
- Presence of other endocrinologic disorders leading to obesity (e.g. Cushing Syndrome).
- Any disorder that is known to affect GH secretion (e.g. untreated hypothyroidism) or use of any medication known to affect GH levels (including glucocorticoids and GH itself).
- Any other disorder that is known to affect stature including skeletal dysplasias.
- Recent use (within two years) of anorexiant medications, stimulant medications, or other medications felt to impact growth.
- Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study.
- Individuals receiving medical treatment other than diet for hypertension or dyslipidemia.
- Individuals with evidence of precocious puberty as defined as palpable breast tissue noted in females before the age of 7, testicular size greater than or equal to 4cc in males before the age of 9, or bone age advancement more than 2 SD for chronologic age.
- Individuals receiving androgen or estrogen hormone therapy.
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2017
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01237041
Start Date
July 1 2011
End Date
December 13 2017
Last Update
December 17 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892