| CTRI Number |
CTRI/2024/05/067727 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of trace elements and Cholesterol in Diabetes Mellitus Patients |
|
Scientific Title of Study
|
Analysing the role of serum Magnesium, Zinc, Copper, Iron and Total Cholesterol in
type-2 Diabetes Mellitus patients in AVBR Hospital , Wardha. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mithila Vinayak Sarware |
| Designation |
Post Graduate Medical Laboratory Technology |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Biochemistry, Datta Meghe Institute of Higher Education and Research , AVBR Hospital, Sawangi Meghe, Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7499456009 |
| Fax |
|
| Email |
mithilav.sarware@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Vagga Manglaram |
| Designation |
Associate Proffesor, Department of Biochemistry.emistry |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Biochemistry, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970001431 |
| Fax |
|
| Email |
anjali.biochemistry@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mithila Vinayak Sarware |
| Designation |
Post Graduate Medical Laboratory Technology |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pathology, Datta Meghe Institute of Higher Education and Research , AVBR Hospital, Sawangi Meghe, Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7499456009 |
| Fax |
|
| Email |
mithilav.sarware@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research, Sawangi Meghe, Wardha-442001, India. |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Sawangi Meghe, Wardh India 442001 |
| Type of Sponsor |
Private 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 |
| Mithila Vinayak Sarware |
Datta Meghe Institute of Higher Education and Research |
Department of Biochemistry, Datta Meghe Institute of Higher Education and Research, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha.
Wardha
MAHARASHTRA |
7499456009
mithilav.sarware@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Datta Meghe Institute of Higher Education and Research, Wardha-442001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged 20-79 years having a history of diabetes for more than 3 years at the time of data collection were included. |
|
| ExclusionCriteria |
| Details |
Patients who were pregnant or lactating, taking any electrolyte-altering drugs, taking nutritional supplements such as magnesium-containing laxatives, suffering from chronic disorders of the liver, kidney, and cardiovascular system, endocrine disorders, established psychiatric disorder and on antidepressant and/or antipsychotic therapy, HIV/AIDS, malignancy, and substance abuse were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of plasma glucose, serum magnesium, copper, zinc, iron, cholesterol will be established in Type 2 diabetes mellitus patients |
Assessments will be done at the end of 18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
22/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Individuals
diagnosed with Type 2 Diabetes Mellitus (T2DM) are more likely to have obesity,
insulin resistance, and a higher incidence of cardiovascular problems in later
life. Insulin production, secretion,
release, and mode of action can all be impacted by trace metal elements . Diabetes mellitus 2 is
linked to changes in the metabolism of trace metals such as magnesium and
copper . Since trace metal elements
are found in many proteins’ prosthetic groups and function as cofactors in
several enzymes, they are naturally occurring inorganic elements that have been
suggested as potential treatments for metabolic disorders. This study aims to analyse the role of serum magnesium, zinc, copper, iron
and total cholesterol in Type 2 Diabetes Mellitus Patients.
|