| CTRI Number |
CTRI/2018/05/014272 [Registered on: 31/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of long-term glycaemic control with blood Angiopoietin-like protein levels in diabetes patients |
|
Scientific Title of Study
|
To study correlation of long term glycaemic control as measured by glycosylated hemoglobin (HbA1c) with serum Angiopoietin-like protein (ANGPTL6) levels in type-II diabetes mellitus patients |
| Trial Acronym |
ANGPTL6 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikaas Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Dept. of Pharmacology, Lady Hardinge Medical College, New Delhi
Central
DELHI
110001
India |
| Phone |
9717918726 |
| Fax |
|
| Email |
sharmavikaas88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lalit Kumar Gupta |
| Designation |
Post Graduate Student; Guide |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Dept. of Pharmacology, Lady Hardinge Medical College, New Delhi
Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India 110001
Central
DELHI
110001
India |
| Phone |
9868234013 |
| Fax |
|
| Email |
lkg71@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikaas Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Dept. of Pharmacology, Lady Hardinge Medical College, New Delhi
DELHI
110001
India |
| Phone |
9717918726 |
| Fax |
|
| Email |
sharmavikaas88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College, Connaught place, New Delhi-110001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Lalit K Gupta |
Lady Hardinge Medical College, Connaught place |
Dr. Lalit K Gupta Chamber, Department of Pharmacology, Lady Hardinge Medical College, Connaught place
Central
DELHI |
9868234013
lkg71@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Human Research, Lady Hardinge Medical College, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type-II Diabetes Mellitus patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Type-II Diabetes Mellitus patients |
|
| ExclusionCriteria |
| Details |
Patients <18yrs of age
Type-I Diabetes Mellitus
Newly diagnosed case(<3 months) of Type-II Dibetes Melltus
Patients taking Insulin therapy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Serum ANGPTL6 levels,
Serum HbA1c levels |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fasting Blood Glucose levels,
General Paameters,
Dose of Drug(s) taken |
3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2012 |
| Date of Study Completion (India) |
31/03/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To study correlation of long term glycaemic control as measured by glycosylated (HbA1c) with serum Angiopoietin-like protein (ANGPTL6) levels in type-II Diabetes Mellitus patients. |