| CTRI Number |
CTRI/2025/10/096636 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Malnutrition Assessment in Elderly Individuals With Type 2 Diabetes |
|
Scientific Title of Study
|
A Study on Malnutrition among Geriatric Patients with Type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fathimath Shaima |
| Designation |
Student |
| Affiliation |
NGSM Institute Of Pharmaceutical sciences |
| Address |
Department Of Pharmacy Practice , NGSM Institute Of Pharmaceutical Sciences , Deralakatte , Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9481417553 |
| Fax |
|
| Email |
fathimathshaima2k22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandakumar UP |
| Designation |
Assistant Professor ll |
| Affiliation |
NGSM Institute Of Pharmaceutical sciences |
| Address |
Department Of Pharmacy Practice , NGSM Institute Of Pharmaceutical Sciences , Deralakatte , Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9633023062 |
| Fax |
|
| Email |
nandakumar@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandakumar UP |
| Designation |
Assistant Professor ll |
| Affiliation |
NGSM Institute Of Pharmaceutical sciences |
| Address |
Department Of Pharmacy Practice , NGSM Institute Of Pharmaceutical Sciences , Deralakatte , Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9633023062 |
| Fax |
|
| Email |
nandakumar@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| NITTE (Deemed to be University) Deralakatte , Mangalore,575018 |
|
|
Primary Sponsor
|
| Name |
NITTE (Deemed to be University) NGSM Institute Of Pharmacetical Sciences |
| Address |
Deralakatte, Mangaluru 575018 |
| Type of Sponsor |
Other [(Educational Institution] |
|
|
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 Shuaib Ahmed MA |
Justice KS Hegde Charitable Hospital |
Department of General Medicine no.10 , ground floor KSHEMA , JKSHCH , Mangaluru
Dakshina Kannada
KARNATAKA |
9880322268
shuaib9800@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute Of Pharmaceutical Sciences |
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 |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Inpatients and outpatients aged between 60 to 90 years, diagnosed with type 2 DM for over one year. |
|
| ExclusionCriteria |
| Details |
-Patients who are critically ill.
-Patient who refuses to give inform consent.
-Patients with comorbid conditions known to independently cause malnutrition (eg:Active cancer, Chronic infections such as Tuberculosis or HIV, Malabsorption syndromes). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence and severity of malnutrition among geriatric patients with type 2 diabetes mellitus assessed using the Mini Nutritional Assessment (MNA). |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of malnutrition with glycemic control, comorbidities, functional status, and quality of life. |
one year |
|
|
Target Sample Size
|
Total Sample Size="296"
Sample Size from India="296"
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)
|
24/11/2025 |
| 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
|
INTRODUCTION: Diabctes mellitus (DM) is a metabolic disorder with a rising global prevalence, posing a major public health challenge in the 21st century. While chronic complications of diabetes mellitus are well recognized, nutrition-related comorbidities like malnutrition often remain overlooked despite their substantial impact. OBJECTIVES OF THE STUDY: To determine the proportion of malnutrition among geriatric type 2 diabetes mellitus patients and to find out the factors affecting malnutrition among them. METHODOLOGY: Participants of either gender aged between 60 to 90 years presenting to the outpatient and inpatient department of general medicine will be enrolled in the study, after getting the informed consent signed from them. All the details pertaining to the socio-demographic and clinical parameters will be recorded in a well-designed data collection form. Status of malnutrition will be assessed using Mini Nutritional Assessment (MNA). STATISTICAL ANALYSIS: Statistical analysis will be done using SPSS 29.0 at 95% confidence interval. Qualitative data will be presented as frequency and percentage. Quantitative data will be presented as mean +/- standard deviation. The proportion of malnutrition will be expressed in terms of frequency and percentage. Factors associated with malnutrition will be analysed using Chi-square/Fisher’s exact test. A p value <0.05 will be considered statistically significant. OUTCOME MEASURES: The study is expected to identify key socio-demographic and clinical factors associated with malnutrition in elderly patients with type 2 diabetes, providing evidence for the development of effective screening strategies and targeted nutritional interventions. |