NCT06469437 The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM
| NCT ID | NCT06469437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Type2diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-07-05 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2024-07-05 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: With the aging of the world population and the increasing incidence of type 2 diabetes mellitus (T2DM) with age, the number of elderly individuals living with diabetes has been considerably rising. It is known that uncontrolled T2DM negatively impacts various health outcomes, including geriatric outcomes such as sarcopenia, frailty, immobility, incontinence, and infections. Current medical literature fails to establish appropriate glycemic targets for different elderly profiles. Although guidelines emphasize the need to individualize targets, there is no concise tool to identify which individuals benefit from each therapeutic approach. Data suggest that frailty is the best predictor of negative outcomes in elderly patients living with T2DM. The Clinical Frailty Scale (CFS) and the 10-minute Targeted Geriatric Assessment (TaGA-10) are validated tools for prognosis in elderly patients and for identifying frail elderly individuals. Methods: Randomized controlled trial. Elderly individuals diagnosed with T2DM at a tertiary care outpatient clinic will be included. All enrolled patients will undergo geriatric assessment using CFS, TaGA-10, and Charlson Comorbidity Index. Patients will be randomized into usual care and intervention groups, and the intervention involves providing the geriatric assessment to the care team to support their decisions. The adequacy of the therapeutic approach will be measured in one week by reviewing the consult record or interviewing the physician. The clinical impact on the frequency of hypoglycemia, falls, infections, hospitalizations, and mortality will be evaluated at 3 and 6 months by telephone interviews. Discussion: Current guidelines recommend using age, comorbidities, cognitive, and functional status to individualize therapeutic targets in elderly patients with T2DM; however, it is possible that these variables alone may not be sufficient to classify all elderly individuals in their complexity adequately. A tool with such power and easy to use in clinical practice is necessary.
Eligibility Criteria
Inclusion Criteria: * Age 60 years or older * Diagnostic of type 2 diabetes mellitus according to American Diabetes Association criteria * Patients under follow-up in a specialized endocrinology outpatient clinic * Patients who have a glycated hemoglobin measurement of up to three months Exclusion Criteria: * Lack of consent for research participation from the patient or the physician * Patients classified as Clinical Frailty Scale 9.
Contact & Investigator
Renato GB Mello, Professor
PRINCIPAL INVESTIGATOR
Federal University of Rio Grande do Sul
Frequently Asked Questions
Who can join the NCT06469437 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Type2diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06469437 currently recruiting?
Yes, NCT06469437 is actively recruiting participants. Contact the research team at gabrielapetitot@gmail.com for enrollment information.
Where is the NCT06469437 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT06469437 clinical trial?
NCT06469437 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Renato GB Mello, Professor at Federal University of Rio Grande do Sul. The trial plans to enroll 220 participants.
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