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CTRI Number  CTRI/2024/11/076468 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association of diabetic status in Cardiovascular, Chronic kidney disease and Retinopathy 
Scientific Title of Study
Modification(s)  
"Cross sectional study of HbA1c levels in patients with cardio and Renal complication and their association with demographic parameters". 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayanthi S 
Designation  Senior Lab Supervisor 
Affiliation  Madras Medical Mission Hospital 
Address  Vels Institute of science technology and Advanced studies (VISTAS) Department of Biochemistry Pallavaram

Thiruvallur
TAMIL NADU
600117
India 
Phone  9884208227  
Fax    
Email  jayanthi.nitish@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jayanthi S 
Designation  Senior Lab Supervisor 
Affiliation  Madras Medical Mission Hospital 
Address  Vels Institute of science technology and Advanced studies (VISTAS) Department of Biochemistry Pallavaram

Thiruvallur
TAMIL NADU
600117
India 
Phone  9884208227  
Fax    
Email  jayanthi.nitish@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jayanthi S 
Designation  Senior Lab Supervisor 
Affiliation  Madras Medical Mission Hospital 
Address  Vels Institute of science technology and Advanced studies (VISTAS) Department of Biochemistry Pallavaram

Thiruvallur
TAMIL NADU
600117
India 
Phone  9884208227  
Fax    
Email  jayanthi.nitish@gmail.com  
 
Source of Monetary or Material Support  
The Madras Medical Mission 4-A Dr.J.J Nagar,Mogappair, Chennai - 600 037. India 
 
Primary Sponsor  
Name  Jayanthi S 
Address  The Madras Medical Mission Department of Biochemistry 4-A, Dr.J.J. Nagar, Mogappair, Chennai-600037 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V Chitra Sree  The Madras Medical Mission  Department of Biochemistry 4-A,Dr.J.J. Nagar Mogappair
Thiruvallur
TAMIL NADU 
09444142211

chitrashree.v@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee The Madras Medical Mission Hospital  Approved 
Institutional Ethics Committee, The Madras Medical Mission  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, (2) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, (3) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Nil 
 
ExclusionCriteria 
Details  Patients with previous and current malignant tumors
Gestational diabetes and type 1 diabetes 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the association of HbA1C in cardiovascular and chronic kidney disease  Baseline, Yearly once up-to 4 years 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the prevalence of thyroid dysfunction among diabetic patients.
Assess the prevalence of dyslipidemia in diabetic patients.
Explore the potential interactions between HbA1C levels and other demographic or clinical variables such as age, gender, BMI, co-morbidities in relation to the mentioned health conditions.

 
3.5 years 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   25/11/2024 
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="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Thesis protocol

Cross sectional study on association of HbA1c with Cardiovascular disease (Macro vascular),Cronic Kidney Disease (Micro vascular complications).

 

Study Team :

Research Scholar         : S.Jayanthi, Sr.Lab Supervisor, MMM Hospital

Guide                          : Dr.P.Amudha , Assistant Professor,

                                      Department of Biochemistry, Vels University

Clinical Guide             :          

      Dr,Mullasari Ajit - Director -  ICVD

Dr.V.Chitra Sree - HOD & Senior Consultant

        Department of Biochemistry  & Haematology

       Dr.Manoj Kumar Shah – Consultant – Diabetologist

 

Introduction:

Diabetes Mellitus has been identified as a contributing factor in a number of conditions, most notably cardiovascular disease, retinal disease, and renal disease. With the constant development of living standards, the increasing incidence of chronic diseases has gradually become important. Diabetes as one of the most important chronic diseases is the most common endocrine system disease.

 Its complications are numerous, and the proportion of diabetes patients with hypertension and cardiovascular and cerebrovascular diseases is increasing, which seriously threatens human health and causes severe social and economic burden. Therefore diabetes has attracted more and more attention.

 A large number of epidemiologic studies suggested that patients with diabetes had several times higher risks of cardiovascular disease and diabetes was a continuous risk factor of cardiovascular disease.

 A distinct manifestation of diabetic renal disease is diabetic nephropathy (DN),which is seen in patients with both type 1 and type 2 diabetes mellitus. DN, commonly a manifestation of uncontrolled DM, is a chronic disease state with glomerular hypertrophy, transient glomerular hyperfiltration, renal fibrosis, proteinuria, and a progressive decrease in glomerular filtration rate (GFR). Anemia is an important component of diabetic nephropathy.

 Thyroid hormones are involved in cell metabolism, blood sugar regulation, and insulin resistance. The prevalence of an abnormal thyroid function is higher in patients with diabetes (approximately 2.2–17% increase) than in healthy individuals. Hypothyroidism is the commonest abnormal thyroid function in Diabetic patients. In addition, thyroid hormones interact with the kidneys. Thyroid hormones contribute to the growth and development of the kidneys, maintain water and electrolyte balance, and participate in the renal transport system. Thyroid dysfunction affects the function of the glomerulus and renal tubules, and indirectly affects the renin–angiotensin system and renal blood flow. Changes in hemodynamics and the cardiovascular system have an effect on renal function.

Dyslipidemia is a well-recognized risk factor for diabetic kidney disease (DKD) in patients with type 2 diabetes (T2D).Dyslipidemia in patients with T2D is typically characterized with high levels of triglyceride (TG) and low density lipoprotein cholesterol (LDL-C), and low level of high density lipoprotein cholesterol (HDL-C)

 People with diabetes can have an eye disease called. Diabetic Retinopathy High blood sugar levels cause damage to blood vessels in the retina. These blood vessels can swell and leak. Or they can close, stopping blood from passing through. Sometimes abnormal, new blood vessels grow on the retina. The condition can develop in anyone who has type 1 or type 2 diabetes.

 

Aim:

1.      To study and correlate on association of HbA1C levels in Macro vascular and Micro, and thyroid dysfunction among people visiting a tertiary care hospital.

 

2.      To identify the severity of the diseases based on the HbA1C levels and duration of diabetes.

 

3.      To compare on the high risk of the studied health condition for diabetic patients.

 

 

Objectives:

1.      To investigate the extent to which the HbA1c levels correlate with the severity of Macro vascular and Micro vascular complication.

2.      To assess the prevalence of Thyroid dysfunction among diabetic patients.

3.      To assess the prevalence of dyslipidemia in diabetic patients.

4.      To explore the potential interactions between HbA1c levels and other demographic or clinical variables such as age, gender, BMI, co-morbidities in relation to the mentioned health conditions. 

 
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