| CTRI Number |
CTRI/2018/12/016746 [Registered on: 19/12/2018] Trial Registered Prospectively |
| Last Modified On: |
13/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Magnesium in health and disease states. |
|
Scientific Title of Study
|
A study of serum magnesium levels in patients with type 2 diabetes mellitus, hypertension, dyslipidemia, coronary artery disease and correlation with ASCVD risk score. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navaneeth S Kamath |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and hospital |
| Address |
Kasturba Medical college and Hospital, 2nd floor, New Sharada Madhav Pai OPD block, room no12, Department of General Medicine, Madhav Nagar, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8951432209 |
| Fax |
|
| Email |
navaneeth.kamath.12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rama Bhat |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College and hospital |
| Address |
Kasturba Medical college and Hospital, Madhav Nagar, 2nd floor New Sharada Madhav Pai OPD block, department of medicine, Kasturba Medical College, Manipal - 576 104, India
Udupi
KARNATAKA
576104
India |
| Phone |
9945272251 |
| Fax |
|
| Email |
ram.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Navaneeth S Kamath |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and hospital |
| Address |
Kasturba Medical college and Hospital, 2nd floor, New Sharada Madhav Pai OPD block, room no 12, Department of General Medicine, Madhav Nagar, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8951432209 |
| Fax |
|
| Email |
navaneeth.kamath.12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal academy of higher education, Kasturba Medical College, Post graduate section, 1 st floor KMC administrative office, Madhav Nagar, Manipal - 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Medicine, Kasturba Medical College and hospital. madhav nagar, Manipal - 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rama Bhat |
Department of Medicine, Kasturba Medical College and hospital. madhav nagar, Manipal - 576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Navaneeth S Kamath |
Kasturba Hospital Manipal |
Kasturba Medical College and hospital,Department of Medicine, 2 nd floor , room no 12, sharada madhav pai OPD block, Madhav Nagar, Udupi District, Manipal - 576104
Udupi
KARNATAKA |
8951432209
navaneeth.kamath.12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (3) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (4) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Type 2 DM, HTN, Dyslipidemia and CAD
and in the age group of 40 to 79 yrs |
|
| ExclusionCriteria |
| Details |
Patients who are having chronic kidney disease, chronic liver disease, endocrinopathy, rheumatologic diseases, magnesium supplements, antacids, diuretics and chronic alcoholic will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome expected in this study would be whether low magnesium levels in blood is associated with Type 2 Diabetes Mellitus, Hypertension, Dyslipidemia and Coronary artery disease and its correlation with ASCVD risk score. Hence there may be a role of magnesium supplementation in preventing these diseases. |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Magnesium levels in only diabetics, magnesium levels in diabetes with hypertension, magnesium levels in diabetes with hypertension and dyslipidemia. |
Day 1 |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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)
|
01/01/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study we would like to measure Serum magnesium levels in patients with diabetes mellitus(DM), hypertension(HTN) ,Dyslipidemia and in CAD and correlate the magnesium levels range in quartiles and show that magnesium levels are lower in these group of individuals with more severe disease than less severe disease. Hence comes the role of Magnesium supplementation in prevention of Type 2 Diabetes, Hypertension, Dyslipidemia and CAD and may have a protective role against these diseases. Also ASCVD risk score shall be calculated for all patients who have Diabetes, Hypertension and Dyslipidemia and ASCVD risk shall be estimated and also correlate whether low magnesium is associated with higher ASCVD risk score. |