Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05645211
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2022-11-30
Brief Title:
The AgRP and GHIGF-1 Axis in Children
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Agouti-related Peptide AgRP and the GHIGF-1 Axis in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recent data support the existence of a GH-Agouti-related peptide AgRP axis The neuropeptide AgRP promotes food intake and has important effects on energy homeostasis Recent evidence suggest that GH stimulates AgRP and AgRP may mediate some of GHs important nutritional and metabolic effects main goals of this project are to characterize for the first time plasma levels of AgRP in children and to determine how these relate to GH and IGF-1 levels age body composition clinical and other endocrine parameters To accomplish this we will conduct two studies one being a cross-sectional study that will measure AgRP levels in 140 healthy children ages 5-17 and the second being a prospective study that will measure the change in plasma AgRP levels in response to GH treatment in 16 children who receive this as part of their clinical care for GH deficiency or short stature
Detailed Description:
Protocol 1 This will be a cross-sectional study in 140 healthy children Participation will include one visit that will take place between 8-9 am and after a fast from midnight the night before
Procedures at the visit will include
1 Review of medical history
2 Anthropometrics measurements Weight height waist and hip circumferences
3 Collection of information from medical record including growth records and physical examination findings including features relevant to pubertal stage in all children and onset of menses in females
4 Assessment of pubertal status and Tanner stage based on physical examination
5 Collection of information on diet activity level and sleep
6 Blood Sampling venous blood will be sampled from a peripheral vein for measurement of AgRP GH IGF-1 leptin SOb-R triglycerides insulin glucose testosteronemales estradiolfemales DHEAS and cortisol levels Insulin and glucose levels will be used to assess insulin resistance by HOMA QUICKI
Protocol 2 This will be a prospective study in 16 children who will be studied before and at 4 time points 1 week 2 weeks 1 month and 2 months after starting GH treatment as part of their clinical care This protocol will study subjects Groups 2 and 3 Growth hormone will not be prescribed as part of this study Children will be treated clinically with GH as prescribed by their Pediatric Endocrinologist for FDA approved indications and according to standard guidelines for dosing for treatment of GH deficiency in children
Each visit that will take place between 8-9 am and after a fast from midnight the night before
Procedures at each visit will include
1 Review of medical history
2 Anthropometrics measurements Weight height waist and hip circumferences skinfold thicknesses
3 Collection of information from medical record including growth records and physical examination findings including features relevant to pubertal stage in all children and onset of menses in females GH dose and compliance will be recorded at follow up visits
4 Collection of information on diet activity level and sleep
5 Blood Sampling Venous blood will be sampled at a peripheral vein for
Baseline pre-GH treatment measurement of AgRP GH IGF-1 IGFBP-3 leptin SOb-R triglycerides insulin and glucose testosteronemales estradiolfemales DHEAS and cortisol levels
Follow up visits on growth hormone measurement of AgRP IGF-1 IGFBP-3 leptin SOb-R triglycerides insulin glucose and cortisol levels
Insulin and glucose levels will be used to assess insulin resistance by HOMA QUICKI
Procedures at the visit will include
1 Review of medical history
2 Anthropometrics measurements Weight height waist and hip circumferences
3 Collection of information from medical record including growth records and physical examination findings including features relevant to pubertal stage in all children and onset of menses in females
4 Assessment of pubertal status and Tanner stage based on physical examination
5 Collection of information on diet activity level and sleep
6 Blood Sampling venous blood will be sampled from a peripheral vein for measurement of AgRP GH IGF-1 leptin SOb-R triglycerides insulin glucose testosteronemales estradiolfemales DHEAS and cortisol levels Insulin and glucose levels will be used to assess insulin resistance by HOMA QUICKI
Protocol 2 This will be a prospective study in 16 children who will be studied before and at 4 time points 1 week 2 weeks 1 month and 2 months after starting GH treatment as part of their clinical care This protocol will study subjects Groups 2 and 3 Growth hormone will not be prescribed as part of this study Children will be treated clinically with GH as prescribed by their Pediatric Endocrinologist for FDA approved indications and according to standard guidelines for dosing for treatment of GH deficiency in children
Each visit that will take place between 8-9 am and after a fast from midnight the night before
Procedures at each visit will include
1 Review of medical history
2 Anthropometrics measurements Weight height waist and hip circumferences skinfold thicknesses
3 Collection of information from medical record including growth records and physical examination findings including features relevant to pubertal stage in all children and onset of menses in females GH dose and compliance will be recorded at follow up visits
4 Collection of information on diet activity level and sleep
5 Blood Sampling Venous blood will be sampled at a peripheral vein for
Baseline pre-GH treatment measurement of AgRP GH IGF-1 IGFBP-3 leptin SOb-R triglycerides insulin and glucose testosteronemales estradiolfemales DHEAS and cortisol levels
Follow up visits on growth hormone measurement of AgRP IGF-1 IGFBP-3 leptin SOb-R triglycerides insulin glucose and cortisol levels
Insulin and glucose levels will be used to assess insulin resistance by HOMA QUICKI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None