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

NCT04304261 | Completed Phase 3

• 1 other identifier: ESCDP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Cognitive Functions Confusion

Keywords

Diabetes mellitus; Cognitive Functions; Sodium glucose transporter

Outcome Measures

Primary Outcomes (1)

• Changes of cognitive function assessed by cognitive function scale

  cognitive function scale

  12 weeks

Secondary Outcomes (3)

• Changes of standardized uptake values of brain and splanchnic organs assessed by 18F-PET-CT

  1 week

• Changes of brain function assessed by near infrared brain functional imaging

  4 week

• Changes of urinary sodium and glucose excretion (mmol/24h)

  1 week

Study Arms (2)

Canagliflozin

EXPERIMENTAL

12 weeks of Canagliflozin(100mg/day) treatment, randomly

Drug: Canagliflozin

Sitagliptin

EXPERIMENTAL

12 weeks of Sitagliptin (100mg/day) treatment, randomly

Drug: Sitagliptin

Interventions

Canagliflozin DRUG

12 weeks of Canagliflozin(100mg/day) treatment

Canagliflozin

Sitagliptin DRUG

12 weeks of Sitagliptin (100mg/day) treatment

Sitagliptin

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly onset type 2 diabetes within 3 months
• %\<HbA1c\<10%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Zhiming Zhu

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Confusion; Diabetes Mellitus

Interventions

Canagliflozin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Triazoles; Azoles; Pyrazines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Hypertension & Endocrinology, Daping Hospital

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: July 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: April 30, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)