| CTRI Number |
CTRI/2025/01/079817 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on the link between Hemoglobin, Blood Sugar, and thinking ability in adults with Type 2 Diabetes in Udupi District |
|
Scientific Title of Study
|
A study to determine the relationship between the level of Hemoglobin (Hb) with
Fasting Blood Sugar (FBS), Glycosylated Hemoglobin (HbA1c) and Cognitive ability among adults
with Type 2 Diabetes Mellitus in selected tertiary care hospital of Udupi District Karnataka India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Clara Pramila Dsouza |
| Designation |
M Sc Nursing Student |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Department of Community Health Nursing/4th Floor/Manipal College of Nursing/ MAHE/ Madhav Nagar,Eshwar Nagar/ Manipal/ Karnataka/ 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986349215 |
| Fax |
|
| Email |
dsouzaclarapramila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeyalakshmi K |
| Designation |
Assistant Professor-Senior Scale |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Department of Community Health Nursing
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886922100 |
| Fax |
|
| Email |
jeyalakshmi.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Clara Pramila Dsouza |
| Designation |
M Sc Nursing Student |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Department of Community Health Nursing/4th Floor/Manipal College of Nursing/ MAHE/ Madhav Nagar,Eshwar Nagar/ Manipal/ Karnataka/ 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986349215 |
| Fax |
|
| Email |
dsouzaclarapramila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Community Health Nursing/4th Floor/Manipal College of Nursing/ MAHE/ Madhav Nagar,Eshwar Nagar/ Manipal/ Karnataka/ 576104 |
|
|
Primary Sponsor
|
| Name |
Clara Pramila Dsouza |
| Address |
Department of Community Health Nursing/4th Floor/Manipal College of Nursing/ MAHE/ Madhav Nagar,Eshwar Nagar/ Manipal/ Karnataka/ 576104 |
| Type of Sponsor |
Other [(Self)] |
|
|
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 |
| Clara Pramila Dsouza |
Kasturba Hospital Manipal |
Department of Medicine
Out patient department
Madhav nagar Manipal
Udupi
KARNATAKA |
09986349215
dsouzaclarapramila@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
OPD of medicine department .
adults taking treatment for Type 2 DM for at least 6 months
willing to participating in the study
those who know to read, write and understand Kannada and English language. |
|
| ExclusionCriteria |
| Details |
aged below 45 years
those who are not able to give any information
those who are not able to comprehend and provide required information for the study
exclude chronic illness such asTB,HIV/AIDS,Cancer (in any situ),
chronic kidney disease, auto immune disease that influences haemoglobin level in blood. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to determine the relationship between Hemoglobin levels and Fasting Blood Sugar, Glycosylated Hemoglobin, and Cognitive ability in adults with Type 2 Diabetes Mellitus. |
5 WEEKS |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
11/02/2025 |
| 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="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
|
The objectives of the study are: 1. To determine the relationship between level of Hb and HbA1c among adults with Type 2 diabetes mellitus 2. To find the relationship between level of Hb and FBS among adults with Type 2 diabetes mellitus 3. To find relationship between level of Hb and cognitive ability among adults with Type 2 diabetes mellitus 4. To find the association between the level of Hb, FBS, HbA1c and selected demographic variables 5. To find the association between cognitive ability and selected demographic variables. This study is justified as it addresses the critical need to understand how hemoglobin levels (Hb) relate to fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c), and cognitive ability in adults with Type 2 Diabetes Mellitus (T2DM) in India. With a high prevalence of T2DM and associated cognitive decline, understanding these relationships is crucial for comprehensive patient care. By focusing on adults with T2DM in tertiary care hospital in Udupi District, Karnataka, this study aims to provide insights that can inform more comprehensive diabetes management strategies and improve clinical practices and policy guidelines. |