| CTRI Number |
CTRI/2025/07/091566 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on how type 2 diabetes affects the heart and daily life |
|
Scientific Title of Study
|
Prediction of cardiovascular disease risk in type 2 diabetes mellitus patients and assessment of health-related quality of life |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aiswarya B |
| Designation |
PG student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy practice,
NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University), Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7736683038 |
| Fax |
|
| Email |
baiswarya338@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy practice,
NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University), Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udayv@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy practice,
NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University), Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udayv@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacy Practice,
NGSM Institute of Pharmaceutical Sciences (Nitte deemed to be university),
Paneer, Deralakatte, Mangaluru, Karnataka-575018 |
| Justice KS Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka-575018 |
|
|
Primary Sponsor
|
| Name |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences (Nitte deemed to be university), Paneer, Deralakatte, Mangaluru, Karnataka-575018 |
| Type of Sponsor |
Other [Academic Institute] |
|
|
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 Uday Venkat Mateti |
Justice KS Hegde Charitable Hospital |
Department of General Medicine,Deralakatte, Mangaluru-575018
Dakshina Kannada
KARNATAKA |
8152977460
udayv@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee(NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients are diagnosed with type 2 diabetes mellitus for at least 12 months. Age between 25 - 84 years. On medications for diabetes management. Patients are open to completing questionnaires and interviews to evaluate their quality of life. Patients are not receiving treatment for cardiovascular disease.
|
|
| ExclusionCriteria |
| Details |
Patients who are diagnosed with type 1 diabetes mellitus or gestational diabetes. Patients with terminal illnesses. Patients with psychiatric illnesses. Patients with type 2 diabetes mellitus who had trauma-related amputations.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Early prediction of CVD risk in type II diabetes mellitus patients will help prevent severe complications.
|
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate health-related quality of life in patients with type 2 diabetes mellitus |
8 months |
| To estimate the association between cardiovascular disease risk scores and quality of life measures in patients with type 2 diabetes mellitus |
8 momths |
|
|
Target Sample Size
|
Total Sample Size="243"
Sample Size from India="243"
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)
|
03/08/2025 |
| 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="0"
Months="8"
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
|
Introduction Cardiovascular disease (CVD) is a major complication of type 2 diabetes mellitus (T2DM), significantly increasing mortality risk. Individuals with T2DM have a 2 to 4 times higher mortality risk due to CVD compared to non-diabetics. Early identification of CVD risk and assessment of quality of life are crucial in improving clinical outcomes for diabetes patients. Tools like QRISK®3 accurately predict CVD risk in T2DM by incorporating multiple clinical and demographic variables. Tools like the ADDQoL assess diabetes-specific QoL. Objective of the study: - To predict the risk of cardiovascular diseases in patients with type 2 diabetes mellitus.
- To assess the health-related quality-of-life parameters in type 2 diabetes mellitus patients.
- To find the relationship between cardiovascular disease risk scores and quality of life scores in type 2 diabetes mellitus patients.
Methodology The Justice K.S. Hegde Charitable Hospital in Mangalore will be the site of this cross-sectional investigation. Purposive sampling will be used to choose a sample size of 243 T2DM patients. Participants must have had diabetes for a minimum of 12 months and range in age from 25 to 84. The 10-year CVD risk will be evaluated using QRISK®3, and the QoL specific to diabetes will be assessed using ADDQoL. Prescriptions, lab reports, and interviews will all be used to gather data. Participants’ privacy will be strictly protected, and ethical approval is required. Inclusion Criteria: - Patients are diagnosed with type 2 diabetes mellitus for at least 12 months.
- Age between 25-84 years.On medications for diabetes management.
- Patients are willing to complete questionnaires and participate in interviews to assess their quality of life.
- Patients are not receiving treatment for cardiovascular disease.
Exclusion criteria: - Patients who are diagnosed with type 1 diabetes mellitus or gestational diabetes.
- Patients with terminal illnesses.
- Patients with psychiatric illnesses.
- Patients with type 2 diabetes mellitus who had trauma-related amputations.
Statistical Analysis: SPSS version 29.0 will be used to enter and analyze all of the data that has been gathered. The mean ± standard deviation or median (IQR) will be used to represent quantitative variables. Karl Pearson or Spearman rank correlation will be used to evaluate the association between QRISK®3 scores and ADDQoL scores Outcome Measurement: The main goal is to use the QRISK®3 tools to predict cardiovascular risk in people with type 2 diabetes. Using ADDQoL to evaluate diabetes-related quality of life. Determining a correlation between QoL scores and CVD risk is an additional measurement. These results will be useful in identifying high-risk patients who require immediate, critical care. The findings are intended to help physicians create individualized treatment programs that consider both psychological and physical factors. This research aims to improve life satisfaction, complications, and patient outcomes for diabetes. |