ObesityPhase 1/2NCT01237041
Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children
A Phase 1/2 study testing Niacin First, Dose-Establishing Study 1 Niacin 250mg and Dose-Establishing Study 1 Niacin 500mg in people with Obesity and Short Stature, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Short Stature, Growth Hormone Deficiency
- What is being tested?
- Niacin First, Dose-Establishing Study 1 Niacin 250mg and Dose-Establishing Study 1 Niacin 500mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2011to 13 Dec 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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%.
Show all 35Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Free Fatty Acids, Body Weight, and Growth Hormone Secretion in Children
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.
Read more
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.
Read the 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 underlies the hyposomatotropinemia of obesity, given that GH production usually normalizes after weight loss. Free fatty acids (FFA) are one factor thought to be involved in regulation of GH secretion. Niacin is a nicotinic acid derivative that inhibits lipolysis and lowers circulating FFA concentrations. Nicotinic acid derivatives have been used in several adult studies examining GH secretion. Specifically in obese adults, inhibition of lipolysis has been found to increase spontaneous and stimulated GH production, presumably due to direct effects of FFA on hypothalamic GH-regulating neurons. Thus far no pediatric studies have examined the effects of niacin on GH secretion, and there is only one small pediatric study of normal weight prepubertal children growing at the 5th-10th percentile in height has tested the effects of lipolytic inhibition by acipimox (a related medication also derived from nicotinic acid) on GH secretion. There are no data in obese children demonstrating the effects of inhibition of lipolysis on GH secretion.
We propose to investigate one of the mechanisms through which high adiposity alters GH secretion in children by testing the effects of inhibiting lipolysis. First we will conduct dose establishing studies to determine the appropriate dose of niacin needed to suppress FFA concentrations in children. We will then conduct the main study, designed as a pilot randomized, double-blind placebo controlled trial of niacin administration, to assess its effects on stimulated GH secretion. We hypothesize that in overweight children niacin will lead to a fall in free fatty acid concentrations and consequently a rise in stimulated GH secretion. We further hypothesize that the overweight subjects will demonstrate stimulated GH secretion profiles with niacin similar to those of control subjects who receive placebo. We expect this pilot study may help improve how diagnostic testing is carried out for growth hormone deficiency in children.
- Conditions
- Obesity, Short Stature, Growth Hormone Deficiency
- Being tested
- Niacin First, Placebo First, Dose-Establishing Study 1 Niacin 250mg, Dose-Establishing Study 1 Niacin 500mg, Dose-Establishing Study 2 Niacin 500mg
- Keywords
- Child, Body Fat, Niacin, Growth Hormone, Obesity, Overweight, Growth Hormones, Short Stature, Children
- Medical subject headings
- Obesity, Dwarfism, Dwarfism, Pituitary, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin FirstDrug
Also called RCT Niacin First
Niacin 500 mg po four times on one of the inpatient days, then placebo on another inpatient day
Placebo FirstDrug
Also called RCT Placebo First
Placebo po four times on one of the inpatient days, then Niacin 500 mg po four times on another inpatient day
Dose-Establishing Study 1 Niacin 250mgDrug
Also called Open-Label Niacin 250mg x 3 doses
Niacin 250 mg po three times at 2 hour intervals on an inpatient day
Dose-Establishing Study 1 Niacin 500mgDrug
Also called Open-Label Niacin 500mg x 3 doses
Niacin 500 mg po three times at 2 hour intervals on an inpatient day
Dose-Establishing Study 2 Niacin 500mgDrug
Also called Open-Label Niacin 500mg x four doses
Open-Label Niacin 500mg four times at 1 hour intervals on an inpatient day
| Study group | Role | What they receive |
|---|---|---|
| Niacin First | Experimental | Subjects receive niacin 500mg hourly for 4 hours on day 1 (at 7:30am, 8:30am, 9:30am, and 10:30am) then cross over to receive placebo hourly for 4 hours on day 2 at (7:30am, 8:30am, 9:30am, and 10:30am). Receives: Drug: Niacin First; Drug: Placebo First |
| Placebo First | Experimental | Subjects receive placebo hourly for 4 hours on day 1 (at 7:30am, 8:30am, 9:30am, and 10:30am) then cross over to receive niacin hourly for 4 hours on day 2 (at 7:30am, 8:30am, 9:30am, and 10:30am). Receives: Drug: Niacin First; Drug: Placebo First |
| Dose-Establishing Study 1 Niacin 250mg | Experimental | Subjects received Niacin 250 mg every 2 hours for 3 doses (at 6am, 8am, and 10am). Receives: Drug: Dose-Establishing Study 1 Niacin 250mg |
| Dose-Establishing Study 1 Niacin 500mg | Experimental | Subjects received Niacin 500 mg every 2 hours for 3 doses (at 6am, 8am, and 10am). Receives: Drug: Dose-Establishing Study 1 Niacin 500mg |
| Dose-Establishing Study 2 Niacin 500mg | Experimental | Subjects received Niacin 500 mg hourly for 4 doses (administered at 7:30am, 8:30am, 9:30am, and 10:30am). Receives: Drug: Dose-Establishing Study 2 Niacin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Hormone Secretion Area Under the Curve in Response to Niacin and Placebo Over Time
Growth hormone Area Under the Curve in response to niacin versus placebo over 4 hours. For growth hormone, samples collected at 0, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
Measured: 4 hours
Secondary outcomes (3)
Free Fatty Acids (FFA) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Effect of niacin vs placebo on Free Fatty Acids (FFA) Area Under the Curve in response to Niacin and Placebo over 4 hours. For FFA, samples collected at 0, 30, 60, 90, 120, 150, 180, 210, and 240 minutes
Measured: 4 hours
Growth Hormone-releasing Hormone (GHRH) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Growth hormone-releasing hormone (GHRH) Area Under the Curve in response to Niacin and Placebo over 4 hours. For GHRH, samples collected at 0, 60, 120, 180, and 240 minutes.
Measured: 4 hours
Somatostatin (SST) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Effect of niacin vs placebo on Somatostatin (SST) Area Under the Curve in response to Niacin and Placebo over 4 hours. For somatostatin, samples collected at 0, 60, 120, 180, and 240 minutes.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study start1 Jul 2011
- Primary completion17 Oct 2017
- Study completion13 Dec 2017
Why it stopped: Study Medication unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- First, we conducted dose-establishing studies using 250mg every 2 hours x 3 doses (2 subjects), 500mg every two hours x 3 doses (5 subjects), and 500mg hourly x 4 doses (5 subjects). This dose-establishing study was followed by the randomized crossover trial using 500mg hourly x 4 doses in conjunction with growth hormone stimulation testing. The RCT was terminated early because of inability to obtain necessary study medications.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Jack Yanovski, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Jack A Yanovski, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237041
- Sponsor's protocol ID
- 110004
- Other IDs
- 11-CH-0004
- Status last verified
- Dec 2018
- First submitted
- 6 Nov 2010
- Last updated
- 17 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Tauber M, Moulin P, Pienkowski C, Jouret B, Rochiccioli P. Growth hormone (GH) retesting and auxological data in 131 GH-deficient patients after completion of treatment. J Clin Endocrinol Metab. 1997 Feb;82(2):352-6. doi: 10.1210/jcem.82.2.3726.
PubMed 9024217Cohen P, Rogol AD, Deal CL, Saenger P, Reiter EO, Ross JL, Chernausek SD, Savage MO, Wit JM; 2007 ISS Consensus Workshop participants. Consensus statement on the diagnosis and treatment of children with idiopathic short stature: a summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop. J Clin Endocrinol Metab. 2008 Nov;93(11):4210-7. doi: 10.1210/jc.2008-0509. Epub 2008 Sep 9.
PubMed 18782877Zucchini S, Pirazzoli P, Baronio F, Gennari M, Bal MO, Balsamo A, Gualandi S, Cicognani A. Effect on adult height of pubertal growth hormone retesting and withdrawal of therapy in patients with previously diagnosed growth hormone deficiency. J Clin Endocrinol Metab. 2006 Nov;91(11):4271-6. doi: 10.1210/jc.2006-0383. Epub 2006 Aug 15.
PubMed 16912138Galescu OA, Crocker MK, Altschul AM, Marwitz SE, Brady SM, Yanovski JA. A pilot study of the effects of niacin administration on free fatty acid and growth hormone concentrations in children with obesity. Pediatr Obes. 2018 Jan;13(1):30-37. doi: 10.1111/ijpo.12184. Epub 2016 Sep 21.
PubMed 27654882
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Fatty Acids, Body Weight, and Growth Hormone Secretion in Children
- ClinicalTrials.gov ID
- NCT01237041
- Acronym / sponsor ID
- 110004
- Conditions
- Obesity, Short Stature, Growth Hormone Deficiency
- Keywords
- Child, Body Fat, Niacin, Growth Hormone, Obesity, Overweight, Growth Hormones, Short Stature
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Medication unavailable
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Posted 17 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 underlies the hyposomatotropinemia of obesity, given that GH production usually normalizes after weight loss. Free fatty acids (FFA) are one factor thought to be involved in regulation of GH secretion. Niacin is a nicotinic acid derivative that inhibits lipolysis and lowers circulating FFA concentrations. Nicotinic acid derivatives have been used in several adult studies examining GH secretion. Specifically in obese adults, inhibition of lipolysis has been found to increase spontaneous and stimulated GH production, presumably due to direct effects of FFA on hypothalamic GH-regulating neurons. Thus far no pediatric studies have examined the effects of niacin on GH secretion, and there is only one small pediatric study of normal weight prepubertal children growing at the 5th-10th percentile in height has tested the effects of lipolytic inhibition by acipimox (a related medication also derived from nicotinic acid) on GH secretion. There are no data in obese children demonstrating the effects of inhibition of lipolysis on GH secretion.
We propose to investigate one of the mechanisms through which high adiposity alters GH secretion in children by testing the effects of inhibiting lipolysis. First we will conduct dose establishing studies to determine the appropriate dose of niacin needed to suppress FFA concentrations in children. We will then conduct the main study, designed as a pilot randomized, double-blind placebo controlled trial of niacin administration, to assess its effects on stimulated GH secretion. We hypothesize that in overweight children niacin will lead to a fall in free fatty acid concentrations and consequently a rise in stimulated GH secretion. We further hypothesize that the overweight subjects will demonstrate stimulated GH secretion profiles with niacin similar to those of control subjects who receive placebo. We expect this pilot study may help improve how diagnostic testing is carried out for growth hormone deficiency in children.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- First, we conducted dose-establishing studies using 250mg every 2 hours x 3 doses (2 subjects), 500mg every two hours x 3 doses (5 subjects), and 500mg hourly x 4 doses (5 subjects). This dose-establishing study was followed by the randomized crossover trial using 500mg hourly x 4 doses in conjunction with growth hormone stimulation testing. The RCT was terminated early because of inability to obtain necessary study medications.
| Arm | Type | Receives |
|---|---|---|
| Niacin First | Experimental | Drug: Niacin First, Drug: Placebo FirstSubjects receive niacin 500mg hourly for 4 hours on day 1 (at 7:30am, 8:30am, 9:30am, and 10:30am) then cross over to receive placebo hourly for 4 hours on day 2 at (7:30am, 8:30am, 9:30am, and 10:30am). |
| Placebo First | Experimental | Drug: Niacin First, Drug: Placebo FirstSubjects receive placebo hourly for 4 hours on day 1 (at 7:30am, 8:30am, 9:30am, and 10:30am) then cross over to receive niacin hourly for 4 hours on day 2 (at 7:30am, 8:30am, 9:30am, and 10:30am). |
| Dose-Establishing Study 1 Niacin 250mg | Experimental | Drug: Dose-Establishing Study 1 Niacin 250mgSubjects received Niacin 250 mg every 2 hours for 3 doses (at 6am, 8am, and 10am). |
| Dose-Establishing Study 1 Niacin 500mg | Experimental | Drug: Dose-Establishing Study 1 Niacin 500mgSubjects received Niacin 500 mg every 2 hours for 3 doses (at 6am, 8am, and 10am). |
| Dose-Establishing Study 2 Niacin 500mg | Experimental | Drug: Dose-Establishing Study 2 Niacin 500mgSubjects received Niacin 500 mg hourly for 4 doses (administered at 7:30am, 8:30am, 9:30am, and 10:30am). |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (35 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niacin FirstAlso: RCT Niacin FirstNiacin 500 mg po four times on one of the inpatient days, then placebo on another inpatient day | Drug | Niacin First, Placebo First |
| Placebo FirstAlso: RCT Placebo FirstPlacebo po four times on one of the inpatient days, then Niacin 500 mg po four times on another inpatient day | Drug | Niacin First, Placebo First |
| Dose-Establishing Study 1 Niacin 250mgAlso: Open-Label Niacin 250mg x 3 dosesNiacin 250 mg po three times at 2 hour intervals on an inpatient day | Drug | Dose-Establishing Study 1 Niacin 250mg |
| Dose-Establishing Study 1 Niacin 500mgAlso: Open-Label Niacin 500mg x 3 dosesNiacin 500 mg po three times at 2 hour intervals on an inpatient day | Drug | Dose-Establishing Study 1 Niacin 500mg |
| Dose-Establishing Study 2 Niacin 500mgAlso: Open-Label Niacin 500mg x four dosesOpen-Label Niacin 500mg four times at 1 hour intervals on an inpatient day | Drug | Dose-Establishing Study 2 Niacin 500mg |
Primary outcome
Growth Hormone Secretion Area Under the Curve in Response to Niacin and Placebo Over Time
Time frame: 4 hours
Growth hormone Area Under the Curve in response to niacin versus placebo over 4 hours. For growth hormone, samples collected at 0, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
3 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9024217Tauber M, Moulin P, Pienkowski C, Jouret B, Rochiccioli P. Growth hormone (GH) retesting and auxological data in 131 GH-deficient patients after completion of treatment. J Clin Endocrinol Metab. 1997 Feb;82(2):352-6. doi: 10.1210/jcem.82.2.3726.
- Background: PubMed 18782877Cohen P, Rogol AD, Deal CL, Saenger P, Reiter EO, Ross JL, Chernausek SD, Savage MO, Wit JM; 2007 ISS Consensus Workshop participants. Consensus statement on the diagnosis and treatment of children with idiopathic short stature: a summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop. J Clin Endocrinol Metab. 2008 Nov;93(11):4210-7. doi: 10.1210/jc.2008-0509. Epub 2008 Sep 9.
- Background: PubMed 16912138Zucchini S, Pirazzoli P, Baronio F, Gennari M, Bal MO, Balsamo A, Gualandi S, Cicognani A. Effect on adult height of pubertal growth hormone retesting and withdrawal of therapy in patients with previously diagnosed growth hormone deficiency. J Clin Endocrinol Metab. 2006 Nov;91(11):4271-6. doi: 10.1210/jc.2006-0383. Epub 2006 Aug 15.
- Background: PubMed 27654882Galescu OA, Crocker MK, Altschul AM, Marwitz SE, Brady SM, Yanovski JA. A pilot study of the effects of niacin administration on free fatty acid and growth hormone concentrations in children with obesity. Pediatr Obes. 2018 Jan;13(1):30-37. doi: 10.1111/ijpo.12184. Epub 2016 Sep 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack A Yanovski, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Niacin First, Dose-Establishing Study 1 Niacin 250mg and Dose-Establishing Study 1 Niacin 500mg in people with Obesity and Short Stature, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth Hormone Secretion Area Under the Curve in Response to Niacin and Placebo Over Time (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237041, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.