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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01237041
• Date of registration: 06/11/2010
• Prospective Registration: Yes
• Primary sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Public title: Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children
• Scientific title: Free Fatty Acids, Body Weight, and Growth Hormone Secretion in Children
• Date of first enrolment: July 1, 2011
• Target sample size: 37
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01237041
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion criteria

- 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:

1. Good general health.

2. Age greater than or equal to 7 and less than 15 years.

3. 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.

4. Weight > 30 kg.

5. Fasting plasma glucose < 100 mg/dL, 2 hour post-dextrose glucose < 140 mg/dL, and
HgbA1C less than or equal to 6.4%.

6. Females who are age 10 or greater must have a negative pregnancy test.

7. 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).

8. 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:

1. Recommended by a pediatric endocrinologist to undergo GH stimulation testing to
establish the diagnosis of GH-deficiency.

2. Good general health.

3. Age greater than or equal to 7 and less than15 years.

4. 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.

5. Weight > 30 kg.

6. Fasting plasma glucose < 100 mg/dL, 2 hour post-dextrose glucose < 140 mg/dL, and
HgbA1C less than or equal to 6.4%.

7. Females who are age 10 or greater must have a negative pregnancy test.

8. Height < 5th percentile.

9. BMI between the 5th and 85th percentiles determined by Centers for Disease Control age
and sex specific data.

10. 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:

1. Baseline creatinine greater than or equal to 1.0 mg/dl.

2. Significant cardiac or pulmonary disease likely to or resulting in hypoxia or
decreased perfusion.

3. Hepatic disease with elevated liver function tests (ALT or AST)greater than or equal
to 1.5 the upper limits of normal.

4. Pregnancy.

5. 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%.

6. Presence of other endocrinologic disorders leading to obesity (e.g. Cushing Syndrome).

7. 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).

8. Any other disorder that is known to affect stature including skeletal dysplasias.

9. Recent use (within two years) of anorexiant medications, stimulant medications, or
other medications felt to impact growth.

10. 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.

11. Individuals receiving medical treatment other than diet for hypertension or
dyslipidemia.

12. 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.

13. Individuals receiving androgen or estrogen hormone therapy.



Age minimum: 7 Years
Age maximum: 14 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Short Stature

Growth Hormone Deficiency

Intervention(s)

Drug: Dose-Establishing Study 1 Niacin 500mg

Drug: Placebo First

Drug: Dose-Establishing Study 1 Niacin 250mg

Drug: Dose-Establishing Study 2 Niacin 500mg

Drug: Niacin First

Primary Outcome(s)

Growth Hormone Secretion Area Under the Curve in Response to Niacin and Placebo Over Time [Time Frame: 4 hours]

Secondary Outcome(s)

Free Fatty Acids (FFA) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours [Time Frame: 4 hours]

Growth Hormone-releasing Hormone (GHRH) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours [Time Frame: 4 hours]

Somatostatin (SST) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours [Time Frame: 4 hours]

Secondary ID(s)

110004

11-CH-0004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01237041