| 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
|
|
|
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
|
|
|
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. |