| CTRI Number |
CTRI/2014/08/004871 [Registered on: 12/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
12/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
observational trio family genetic study |
| Study Design |
Other |
|
Public Title of Study
|
Association of genetic variants of pancreastatin with metabolic disorders in a trio family study |
|
Scientific Title of Study
|
Association of genetic variants of pancreastatin in a trio family study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajit mullasari |
| Designation |
Director of cardiology |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
No 4A, Dr.J.j.Nagar, Mogappair, Chennai
No 4A, Dr.J.j.Nagar, Mogappair, Chennai
Chennai
TAMIL NADU
600037
India |
| Phone |
26565974 |
| Fax |
26565974 |
| Email |
clireco@mmm.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajit mullasari |
| Designation |
Director of cardiology |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
No 4A, Dr.J.j.Nagar, Mogappair, Chennai
No 4A, Dr.J.j.Nagar, Mogappair, Chennai
Chennai
TAMIL NADU
600037
India |
| Phone |
26565974 |
| Fax |
26565974 |
| Email |
clireco@mmm.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajit mullasari |
| Designation |
Director of cardiology |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
No 4A, Dr.J.j.Nagar, Mogappair, Chennai
No 4A, Dr.J.j.Nagar, Mogappair, Chennai
Chennai
TAMIL NADU
600037
India |
| Phone |
26565974 |
| Fax |
26565974 |
| Email |
clireco@mmm.org.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
The Madras Medical Mission |
| Address |
No 4A Dr J J Nagar Mogappair chennai 600037 |
| 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 Ajit Mullasari |
The Madras Medical Mission Hospital |
The Madras Medical Mission Hospital No 4 A Dr J J Nagar Mogappair chennai 600037
Chennai
TAMIL NADU |
26565974
26565974
clireco@mmm.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with PST Ser 297 allele, their parents and siblings |
|
| ExclusionCriteria |
| Details |
Patients without Ser 297 allele |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of gene polymorphism with Diabetic mellitus. |
Association of gene polymorphism with Diabetic mellitus. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Possibility of Diabetic or hypertension in future |
possibility of Diabetic or hypertension in future |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
01/08/2014 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Blood sample collected from families to see pattern of inheritance of the variants |