| CTRI Number |
CTRI/2024/12/078624 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The study of effect of metformin on heart disease risk, vitamin levels, and homocysteine in people with and without type 2 diabetes |
|
Scientific Title of Study
|
Correlation between Atherogenic Index of Plasma (AIP), Folic Acid, Vitamin B12, and Homocysteine Levels in Nondiabetic and Type 2 diabetic subjects: Impact of Metformin Treatment. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Pratiksha Batulwar |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Biochemistry, ground floor JNMC Building, Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7666870865 |
| Fax |
|
| Email |
pratiksha.s.battulwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ashish Anjankar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Biochemistry, ground floor JNMC Building, Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970951055 |
| Fax |
|
| Email |
ashish.anjankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Ashish Anjankar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Biochemistry, ground floor JNMC Building, Sawangi, Wardha
MAHARASHTRA
442001
India |
| Phone |
9970951055 |
| Fax |
|
| Email |
ashish.anjankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research,Sawangi, Wardha,India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi, Wardha,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 |
| Pratiksha Batulwar |
Acharya Vinoba Bhave, Rular Hospital |
Department of Biochemistry ground floor, JNMC building, sawangi, Wardha.
Wardha
MAHARASHTRA |
7666870865
pratiksha.s.battulwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient with type 2 diabetes mellitus with Metformin therapy.
2) Patient with type 2 diabetes mellitus without Metformin therapy.
3) Age more than 30 yr.
|
|
| ExclusionCriteria |
| Details |
1. Patient with other systemic disease.
2. Patient with comorbidities.
3. Immunocompromised patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of cardiovascular risk in nondiabetic and type 2 diabetic patients with or without metformin treatment. |
Assesment will be done at the end of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="207"
Sample Size from India="207"
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)
|
01/01/2025 |
| 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="6"
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
|
AIP, or the atherogenic index of plasma, is a new
indicator of atherogenicity and cardiometabolic health that is made up of
triglycerides and high-density lipoprotein cholesterol. AIP has been linked to
a higher incidence of major adverse cardiovascular events (MACEs) in patients
with high cardiovascular (CV) disease risk and type 2 diabetes mellitus.
Globally, diabetes mellitus (DM) is the most prevalent metabolic disease. As a
result, the disease is becoming more and more common worldwide. Adults with
type-2 diabetes (T2DM) can maintain control of their condition by taking
metformin, an oral hypoglycemic medication, as a first-line treatment. The
majority of diabetic patients on metformin have been observed to be deficient
in vitamin B12 and folic acid (B6). This water-soluble vitamin is mostly found
in animal products like meat. There is additional evidence from a number of
studies linking vitamin B12 deficiency to reduced vitamin B12 absorption in
T2DM patients receiving metformin. Vitamin B12 deficiency may cause serious
complications for people with type 2 diabetes. Our objective was to assess the
relationship between the effects of metformin and the levels of homocysteine,
folic acid, vitamin B12, and the atherogenic index of plasma (AIP) in healthy
individuals and those with type 2 diabetes. |