| 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
|
|
|
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 -80â°C. 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 |