Effects of SGLT2i on the Cognitive Function in T2DM Patient (ESCDP)

Diabetes Mellitus, Type 2 Clinical Trial

— ESCDP  

Official title:

Effects of Sodium-glucose Co-transporter-2 Inhibitors on the Cognitive Function in Type 2 Diabetic Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04304261
• Other study ID #: ESCDP
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 30, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Newly onset type 2 diabetes within 3 months

• 7%<HbA1c<10%

Exclusion Criteria:

• Type 2 diabetes with acute diabetic complications.

• Type1 diabetes.

• Thyroid dysfuncition.

• 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.

• 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.

• Acute infections, tumor, severe arrhythmia.

• Alcohol or medicine addiction, psychoactive substance abuse.

• 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.)

• Fertile woman without contraceptives.

• Allergic to or have contraindication to the intervention drugs.

Related Conditions & MeSH terms

• Cognitive Functions Confusion
• Confusion
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Canagliflozin
12 weeks of Canagliflozin(100mg/day) treatment
• Sitagliptin
12 weeks of Sitagliptin (100mg/day) treatment

Locations

Country	Name	City	State
China	Zhiming Zhu	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of cognitive function assessed by cognitive function scale	cognitive function scale	12 weeks
Secondary	Changes of standardized uptake values of brain and splanchnic organs assessed by 18F-PET-CT	18F-PET-CT	1 week
Secondary	Changes of brain function assessed by near infrared brain functional imaging	near infrared brain functional imaging	4 week
Secondary	Changes of urinary sodium and glucose excretion (mmol/24h)	urinary sodium and glucose excretion	1 week