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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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