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Clinical Trials/CTRI/2025/10/096636
CTRI/2025/10/096636Not yet recruitingNot Applicable

A Study on Malnutrition among Geriatric Patients with Type 2 Diabetes Mellitus

NITTE (Deemed to be University) NGSM Institute Of Pharmacetical Sciences1 site in 1 country296 target enrollmentStarted: November 24, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
296
Locations
1
Primary Endpoint
Prevalence and severity of malnutrition among geriatric patients with type 2 diabetes mellitus assessed using the Mini Nutritional Assessment (MNA).

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
60.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Inpatients and outpatients aged between 60 to 90 years, diagnosed with type 2 DM for over one year.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

Prevalence and severity of malnutrition among geriatric patients with type 2 diabetes mellitus assessed using the Mini Nutritional Assessment (MNA).

Time Frame: at baseline

Secondary Outcomes

  • Association of malnutrition with glycemic control, comorbidities, functional status, and quality of life.(one year)

Investigators

Sponsor
NITTE (Deemed to be University) NGSM Institute Of Pharmacetical Sciences
Sponsor Class
Other [(Educational Institution]
Responsible Party
Principal Investigator
Principal Investigator

Fathimath Shaima

NGSM Institute Of Pharmaceutical sciences

Study Sites (1)

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