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NCT Number: NCT04304261

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cognitive Functions Confusion Confusion Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhiming Zhu

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Canagliflozin

Drug

12 weeks of Canagliflozin(100mg/day) treatment

Sitagliptin

Drug

12 weeks of Sitagliptin (100mg/day) treatment

Primary outcomes

  1. Changes of cognitive function assessed by cognitive function scale

    Time frame: 12 weeks

    cognitive function scale

Secondary outcomes

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

    Time frame: 1 week

    18F-PET-CT

  2. Changes of brain function assessed by near infrared brain functional imaging

    Time frame: 4 week

    near infrared brain functional imaging

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

    Time frame: 1 week

    urinary sodium and glucose excretion

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

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

Acronym: ESCDP

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 11, 2020
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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