Type 2 Diabetes MellitusNCT06212778
Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
An observational study of Type 2 Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Sep 2023to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospitalized older adults with type 2 diabetes mellitus.
Who may be able to join
- People who are aged 60 or above
- Diagnosed with type 2 diabetes mellitus
- Conscious and agree to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
About this study
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.
Read the detailed 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.
- Conditions
- Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue Symptom Inventory
Measured: 30 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start26 Sep 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212778
- Sponsor's protocol ID
- 202309041RINB
- Status last verified
- Sep 2023
- First submitted
- 9 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT06212778
- Acronym / sponsor ID
- 202309041RINB
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized older adults with type 2 diabetes mellitus.
Key inclusion criteria (3 listed)
- People who are aged 60 or above
- Diagnosed with type 2 diabetes mellitus
- Conscious and agree to participate in the study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue
Time frame: 30 mins
Fatigue Symptom Inventory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Yan Liang (+886-2312-3456 ext. 288439, b09406006@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 30 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.