NCT04304261CompletedPhase 3
Effects of SGLT2i on the Cognitive Function in T2DM Patient (ESCDP)
Effects of Sodium-glucose Co-transporter-2 Inhibitors on the Cognitive Function in Type 2 Diabetic Patient
Source: ClinicalTrials.gov · Last updated 30 May 2024
Brief summary (registry, in English)
Type 2 diabetes is associated with diabetic cognopathy, the prevalence of Alzheimer's Disease(AD) in T2DM patients is 1.5 to 2.5 times higher than the general population. Cognitive impairment seriously affects the health and quality of life of the elderly. Prevention and treatment measures for cognitive decline in persons with T2DM has not been well studied. Sodium-glucose transporter-2 (SGLT-2) inhibitors, which lower serum glucose by inhibiting SGLT2-mediated glucose reabsorption in renal proximal tubules, could be neuroprotective. It was recently reported that the SGLT-2 inhibitor improved cognitive function and ameliorated oxidative stress via attenuating mitochondrial dysfunction, insulin resistance, inflammation, and apoptosis in mice or HFD-induced obese rats, that means SGLT-2 inhibitor may provide neuroprotection in the diabetic brain. Hence, Invokana (Canagliflozin) might act as a potent dual inhibitor of AChE and SGLT2. Since the development of diabetes is associated with AD, the design of new AChE inhibitors based on antidiabetic drug scaffolds would be particularly beneficial. Moreover, the present computational study reveals that Invokana (Canagliflozin) is expected to form the basis of a future dual therapy against diabetes associated neurological disorders. The overall goal of this study is to explore the effects of SGLT2 inhibitor on the cognitive function in patients with type 2 diabetes mellitus and make further contribution to the improvement of cognitive function.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 9 Mar 2020
- Start date
- 1 Jul 2021
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- Third Military Medical University
- Diseases
- Type 2 diabetes
- NCT number
- NCT04304261
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 100
- From 1 Jul 2021 to the primary completion date, 1 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 2 diabetes with acute diabetic complications.
- Type1 diabetes.
- Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
- History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
- Acute infections, tumor, severe arrhythmia.
- Other diseases affecting cognitive function (congenital dementia, brain trauma, parkinson's diseases, toxicencephacopathy,epilepsy, mental disorders, severe lungdy sfunction, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, etc.)
- Allergic to or have contraindication to the intervention drugs.
Lab values
- Hepatic insufficiency (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
- Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
Other
- Thyroid dysfuncition.
- Alcohol or medicine addiction, psychoactive substance abuse.
- Fertile woman without contraceptives.
Who the study is looking for
- Newly onset type 2 diabetes within 3 months
- 7%\<HbA1c\<10%
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhiming Zhu Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.