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临床试验/CTRI/2025/10/096636
CTRI/2025/10/096636尚未招募不适用

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

NITTE (Deemed to be University) NGSM Institute Of Pharmacetical Sciences1 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2025年11月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
296
试验地点
1
主要终点
Prevalence and severity of malnutrition among geriatric patients with type 2 diabetes mellitus assessed using the Mini Nutritional Assessment (MNA).

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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).

结局指标

主要结局

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

时间窗: at baseline

次要结局

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

研究者

发起方
NITTE (Deemed to be University) NGSM Institute Of Pharmacetical Sciences
申办方类型
Other [(Educational Institution]
责任方
Principal Investigator
主要研究者

Fathimath Shaima

NGSM Institute Of Pharmaceutical sciences

研究点 (1)

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