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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06212778
Other study ID # 202309041RINB
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 26, 2023
Est. completion date February 29, 2024

Study information

Verified date September 2023
Source National Taiwan University Hospital
Contact Yu Yan Liang
Phone +886-2312-3456
Email b09406006@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

As the proportion of the elderly population increases, so does the number of people suffering from diabetes mellitus (DM). Fatigue is common in elderly patients with type 2 diabetes, and malnutrition may lead to a decrease in muscle strength, thereby aggravating their fatigue symptoms; however, there is still a lack of relevant research on this group in Taiwan. Therefore, the purposes of this study are to understand the current status and correlation of basic attributes, nutritional status, handgrip strength and fatigue in hospitalized older adults with type 2 diabetes mellitus.


Description:

Diabetes mellitus (DM)is increasing among the elderly population in Taiwan, and fatigue is a common troublesome symptom that likely impacts their quality of life and diabetes self-management. Malnutrition is one of the causes of fatigue symptoms in the elderly, and the worse the nutritional status, the worse the hand grip strength performance; the better the grip strength performance, the lower the degree of fatigue symptoms. It can be inferred that the worse the nutritional status, the worse the handgrip strength, which will in turn have an aggravating impact on fatigue symptoms. According to previous literature, handgrip strength may be an important mediating variable between nutritional status and fatigue. However, there are still no relevant studies on hospitalized older adults with type 2 diabetes mellitus. Therefore, the purposes of this study are to: (1) understand the basic attributes, nutritional status, handgrip strength and fatigue symptoms in hospitalized older adults with type 2 diabetes mellitus. (2) explore the correlation between nutritional status, handgrip strength and fatigue symptoms in hospitalized older adults with type 2 diabetes mellitus, so as to serve as a reference for future clinical care to improve fatigue in elderly patients with type 2 diabetes mellitus. This study adopted a cross-sectional, correlational design, using structured questionnaires and a Camry Digital Handgrip Dynamometer to collect data. Participants will be recruited from a metabolism & endocrinology ward at a medical center in northern Taiwan using purposive sampling. The Chinese version of a structured questionnaire, including the demographic and clinical characteristic form, the Mini Nutritional Assessment , and the Fatigue Symptom Inventory will be used. A sample of 54 participants with type 2 diabetes mellitus will be recruited.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date February 29, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - People who are aged 60 or above - Diagnosed with type 2 diabetes mellitus - Conscious and agree to participate in the study. Exclusion Criteria: - People who have a cognitive impairment or unable to communicate - Unable to use the handgrip dynamometer with their dominant hand - Under active treatment for cancer.

Study Design


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue Fatigue Symptom Inventory 30 mins
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