| CTRI Number |
CTRI/2025/04/084660 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Growth Hormone Deficiency |
|
Scientific Title of Study
|
Diagnostic Utility of the ratio of Serum Insulin like Growth Factor-1 to its Serum Binding Protein-3 in Growth Hormone Deficiency in comparison to Clonidine Stimulation Test |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meenakshi B Ramanna |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University, Belagavi |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, KLE University, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9900184188 |
| Fax |
|
| Email |
meenakshi.br@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Meenakshi B Ramanna |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University, Belagavi |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, KLE University, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9900184188 |
| Fax |
|
| Email |
meenakshi.br@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Meenakshi B Ramanna |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University, Belagavi |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, KLE University, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9900184188 |
| Fax |
|
| Email |
meenakshi.br@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research, Nehru Nagar, Belagavi 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
JNMC Campus, Nehru Nagar, Belagavi 590010, Karnataka, INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meenakshi B Ramanna |
KLEs Dr Prabhakar Kore Hospital |
OPD No 3, Department of Paediatrics, Division of Paediatric Endocrinology, KLEs Dr Prabhakar Kore Hospital , Nehru Nagar, Belgaum 590010 Belgaum KARNATAKA |
9900184188
meenakshi.br@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E343||Short stature due to endocrine disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
All Children between 4-16years presenting to Paediatric and Paediatric Endocrinology OPD with Short Stature fulfilling the Clinical and/or Auxological criteria for Growth Hormone Deficiency |
|
| ExclusionCriteria |
| Details |
Syndromic Short Stature
Chronic Organic illness, Chronic Anaemia, Malnutrition, Chronic kidney disease, chronic liver disorders,
Congenital Heart Disease
Skeletal Dysplasia or other disorders of bone mineralization
Untreated Hypothyroidism , Hypogonadism, Multiple Pituitary Hormone Deficiency
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To analyse serum IGF1 to serum IGFBP3 ratio in diagnosis of Growth Hormone Deficiency
|
At Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study diagnostic utility of Serum IGF1 in Growth Hormone Deficiency
To study diagnostic utility of Serum IGFBP3 in Growth Hormone Deficiency
To study diagnostic utility of Serum IGF1 to Serum IGFBP3 ratio in combination with Serum IGF1 & Serum IGFBP3 in Growth Hormone Deficiency
|
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: “Diagnostic utility of the ratio of Serum Insulin like Growth Factor-1 (IGF-1) to its Serum Binding Protein-3 (IGFBP-3) in Growth Hormone Deficiency in comparison to Clonidine Stimulation Test” Growth hormone deficiency (GHD) is an important treatable cause of short stature (SS) in children. Its diagnosis however proves to be rather difficult because of a true gold standard diagnostic test. Classically hormonal evaluation for GHD is established by Growth Hormone Stimulation Test. However GH stimulation tests do not demonstrate perfect sensitivity or specificity allowing for potential false-negative or false-positive results. Other drawbacks of GH stimulation tests namely time-consuming invasive nonphysiological nonreproducible and potentially hazardous nature. It has motivated investigators to search for more promising diagnostic tools. Insulin like Growth Factor (IGF-1) concentration is most widely used for the diagnosis of GHD. However more than half the therapeutic response is accounted for by variability in the serum concentrations of IGF-1 and Insulin like Growth Factor Binding Protein (IGFBP-3). So IGF-1 and IGFBP-3 molar ratio is used as biochemical marker to diagnose growth hormone deficiency. Very few studies have investigated the utility of serum IGF-1 to IGFBP-3 ratio in the diagnosis of GHD. This study aims to investigate the performance of the IGF-1, IGFBP-3 independently and in combination with serum IGF-1 and IGFBP-3 ratio and to compare GH stimulation test in the diagnosis of GHD in children with Short Stature. |