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CTRI Number  CTRI/2024/02/063321 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 24/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Inflammatory biomarkers in diabetes patients of different body weight categories 
Scientific Title of Study   Evaluation of emerging inflammatory biomarkers in T2DM subjects across BMI spectrum. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayeshani Mishra 
Designation  Student 
Affiliation  Kasturba Medical College 
Address  Department of Biochemistry Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9569311070  
Fax    
Email  ayeshani.kmcmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Varashree BS 
Designation  Professor & Head 
Affiliation  Kasturba Medical College 
Address  Department of Biochemistry Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202922326  
Fax    
Email  varashree.bs@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Varashree BS 
Designation  Professor & Head 
Affiliation  Kasturba Medical College 
Address  Department of Biochemistry Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202922326  
Fax    
Email  varashree.bs@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal Karnataka 576104 
 
Primary Sponsor  
Name  MAHE Manipal 
Address  Department of Biochemistry Kasturba Medical College Manipal 
Type of Sponsor  Private medical college 
 
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 Varashree BS  Kasturba Medical College, Manipal  Department of Biochemistry, KMC, Manipal
Udupi
KARNATAKA 
08202922326

varashree.bs@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All healthy individuals visiting the Hospital for routine health check-ups between the age of 30 to 60 years can be included in the study. 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Cases: Newly diagnosed cases of T2DM within 5 years of diagnosis, not on insulin, without any secondary complications of diabetes mellitus, will be included in the study.
Controls: Healthy individuals coming for routine health check up will be evaluated and recruited as controls. 
 
ExclusionCriteria 
Details  Cases: Patients diagnosed with diabetes for a period of more than 5 years or patients with advanced micro and macrovascular complications of diabetes, or patients on insulin injections will be excluded from the study.
Controls: Patients diagnosed with diabetes, thyroid disorders, or any other chronic lifestyle diseases (except hypertension), patients with acute infective illness, and patients on drugs that might alter glucose homeostasis (such as corticosteroids), trauma patients, and pregnant women will be 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 between target analytes and biochemical and metabolic markers  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of target analyses with BMI & HbA1c  At baseline 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
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)   05/03/2024 
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="0"
Months="3"
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  

Diabetes affects 422 million people globally, with the majority living in low- and middle-income countries. It is a carbohydrate metabolism disorder characterized by hyperglycemias, insulin resistance, and altered lipid and amino acid metabolism. Diagnosis tests include fasting sugar >126mg/dL, HbA1c >6.5%, and random blood sugar >200 mg/dL. Long-term consequences include microvascular complications like retinopathy and neuropathies, and macrovascular complications like cardiovascular diseases and stroke. Chronic systemic low-grade inflammation is key to the pathogenesis and progression of type 2 diabetes mellitus. Obesity is the main risk factor for the initiation and progression of T2DM and other metabolic syndrome spectrum disorders. The Activin A-Follistatin system has emerged as a potential predictor of inflammation and homeostasis of glucose and lipids, showing promise as a risk stratification index or prognostic marker of T2DM progression. This study aims to explore circulating levels of activin A, follistatin, and the activin A: follistatin ratio in T2DM patients with normal BMI and compare them with overweight T2DM patients. It also aims to correlate the above inflammatory markers with biochemical and haematological markers, along with determining effect of comorbidities and lifestyle on these inflammatory markers.


Understanding the role of activin A, follistatin, and activin A: follistatin ratio in obesity, inflammation, glycemic status, and lipid homeostasis in T2DM patients can provide insights into inflammatory status, guide early anti-inflammatory therapy introduction, and assess the effects of dietary, lifestyle, and psychosocial interventions.

 
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