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CTRI Number  CTRI/2024/04/066456 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Studies on insulin deficiency in pre-diabetic participants  
Scientific Title of Study   Multi-Omics markers validation in pre-diabetic individuals to find correlations with insulin deficiency.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Multi-Omics markers 01, Version: 1  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mitnala Sasikala  
Designation  Director, Research 
Affiliation  Translational research centre,Asian Healthcare Foundation 
Address  Department of Molecular Biochemistry and Molecular Biology Facility Block 6th Floor Room No 1 AIG Hospitals Gachibowli Hyderabad Hyderabad TELANGANA 500032 India
Hyderabad TELANGANA 500032 India
Hyderabad
TELANGANA
500032
India 
Phone  9247164730  
Fax    
Email  drsasikala.mitnala@aighospitals.com  
 
Details of Contact Person
Scientific Query
 
Name  Mitnala Sasikala  
Designation  Director, Research 
Affiliation  Translational research centre,Asian Healthcare Foundation 
Address  Department of Molecular Biochemistry and Molecular Biology Facility Block 6th Floor Room No 1 AIG Hospitals Gachibowli Hyderabad Hyderabad TELANGANA 500032 India
Hyderabad TELANGANA 500032 India
Hyderabad
TELANGANA
500032
India 
Phone  9247164730  
Fax    
Email  drsasikala.mitnala@aighospitals.com  
 
Details of Contact Person
Public Query
 
Name  Mitnala Sasikala  
Designation  Director, Research 
Affiliation  Translational research centre,Asian Healthcare Foundation 
Address  Department of Molecular Biochemistry and Molecular Biology Facility Block 6th Floor Room No 1 AIG Hospitals Gachibowli Hyderabad Hyderabad TELANGANA 500032 India
Hyderabad TELANGANA 500032 India
Hyderabad
TELANGANA
500032
India 
Phone  9247164730  
Fax    
Email  drsasikala.mitnala@aighospitals.com  
 
Source of Monetary or Material Support  
Asian Healthcare Foundation 5th and 6th floors Tower B, AIG Hospitals, Sy No. 136, 4/5 P.Janardhan Reddy Nagar, Gachibowli Hyderabad 500032 India  
 
Primary Sponsor  
Name  DBT Wellcome Trust India Alliance 
Address  Nishant House, 8-2-351/N/1, Rd Number 2, Venkateshwara Hills, Banjara Hills, Hyderabad, Telangana 500034  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Asian Healthcare Foundation  Tower B 6th Floor Room No 1 AIG Hospitals Gachibowli Hyderabad  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mitnala Sasikala  Asian Healthcare Foundation  Department of Molecular Biochemistry and Molecular Biology Facility Block 6th Floor Room No 1 AIG Hospitals Gachibowli Hyderabad Hyderabad TELANGANA 500032 India Hyderabad TELANGANA
Hyderabad
TELANGANA 
9247164730

drsasikala.mitnala@aighospitals.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee of Asian Institute of Gastroenterology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy or Prediabetes 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Controls:
BMI less than 25 kg/m2
2-hour glucose on OGTT ,140 mg/dl
Prediabetes:
BMI less than 25 kg/m2
2-hour glucose on OGTT ,140-199 mg/dl  
 
ExclusionCriteria 
Details  Individuals below 18 years and above 45 years of age,
BMI more than 25 kg/m2,
Individuals with chronic diseases and drug intake,
pregnant and lactating females
patients who have diabetes related-complications or other co-morbidities
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relative contributions of insulin resistance and insulin deficiency to type2 diabetes in India   18 months  
 
Secondary Outcome  
Outcome  TimePoints 
correlations between islet biomarker and insulin deficiency   48 months  
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   15/05/2024 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  


This is a clinical cohort study to assess disease progression by baseline pathophysiology - insulin resistance and insulin secretion. A total 2000 healthy individuals will be screened through a clinical questionnaire and physical examination to exclude chronic disease/ drug intake. All the individuals will undergo oral glucose tolerance test. individuals with 2 hour glucose more between 140-199 mg/dl will be considered to have prediabetes and those individuals with 2 hour glucose less than 140mg/dl will be considered controls.Total 200 prediabetc and 50 healthy controls will be recruited in year 1.After obtaining written consent form, participant will provide 3 aliquots of 5ml whole blood, one will be used for biochemical fasting assay (fasting C-peptide, glucagon, somatostatin, polypeptide levels, lipids, liver function test, and HOMA IR, HOMA S, HbA1c) and other 2 aliquots will be stored at -80⁰C. Individuals who are matched for age, gender, and BMI will return for clamp study. Hyperglycaemic clamps studies will be conducted on these 250 individuals and will be carefully followed to assess disease progression by baseline pathophysiology (insulin secretion and insulin resistance). In addition, all individuals screened for the study will have oral glucose tolerance (2hr-OGTT) and bio specimens stored for future validation. The hyperglycaemic clamp study will be repeated on the pre-DM and control individuals at the end of 3 years and 5 years to measure the changes in insulin secretion level. Additionally, biomarkeres identified in the islet OMICS study will be validated in the clinical cohort to assess if any of these markers correlate with insulin secretion  

 
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