Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children

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. Current tests of growth hormone (such as those used when evaluating the heights of children who are markedly shorter than other children of comparable age) may be affected by other factors, including obesity. Researchers are interested in evaluating the levels of growth hormone and free fatty acids in the blood of children between 7 and 14 years of age who weigh more than children of a comparable age, or who are shorter than other children of a comparable age and have been recommended for growth hormone testing as part of an evaluation for their height.

Objectives:

\- To determine the effect of changes in free fatty acids in the blood on changes in growth hormone secretion in overweight or shorter children and young adolescents.

Eligibility:

\- Children and adolescents between 7 and 14 years of age who weigh more than or are shorter than other children of a comparable age and do not have any medical illnesses.

Design:

* Participants will have two study visits, one of which will be a half day screening visit in the outpatient clinic and one of which will require 2 nights as an inpatient at the National Institutes of Health Clinical Center.
* Participants should not eat or drink anything except water after 10 PM the night before or on the morning of the screening visit.
* At the screening visit, participants will have a physical examination and medical history, provide blood and urine samples, have an oral glucose tolerance test (to check blood sugar levels), and have an x-ray of the left hand to check bone age.
* The inpatient study visit will involve a physical examination and medical history, a full x-ray scan to study body fat and muscle, frequent blood tests throughout the visit, and various medications to stimulate growth hormone production and lower levels of free fatty acids in the blood.

Conditions

• Obesity
• Short Stature
• Growth Hormone Deficiency

Interventions

DRUG

Niacin First

Niacin 500 mg po four times on one of the inpatient days, then placebo on another inpatient day

DRUG

Placebo First

Placebo po four times on one of the inpatient days, then Niacin 500 mg po four times on another inpatient day

DRUG

Dose-Establishing Study 1 Niacin 250mg

Niacin 250 mg po three times at 2 hour intervals on an inpatient day

DRUG

Dose-Establishing Study 1 Niacin 500mg

Niacin 500 mg po three times at 2 hour intervals on an inpatient day

DRUG

Dose-Establishing Study 2 Niacin 500mg

Open-Label Niacin 500mg four times at 1 hour intervals on an inpatient day

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  lead NIH

Principal Investigators

• Jack A Yanovski, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

7 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-07-01

Primary Completion

2017-10-17

Completion

2017-12-13

FDA Drug

Yes

Countries

• United States

Study Locations