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

March 9, 2020 updated by: Zhiming Zhu, Third Military Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • The third hospital affiliated to the Army Medical University
        • Contact:
        • Principal Investigator:
          • Zhu Zhiming, MD
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Zhiming Zhu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Early onset type 2 diabetes within 3 months 7%<HbA1c<10%

Exclusion Criteria:

  • Type 2 diabetes with acute diabetic complications. Type1 diabetes. Other diseases affecting cognitive function (congenital dementia, brain trauma, severe heartdysfunction,severekidneydysfunction,severelungdysfunction, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, etc.); Alcohol abuse,mental illness and psychoactive substance abuse History of thyroid disease Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.

Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.

History of depression, schizophrenia or dementia. History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.

History of parkinson's diseases, head injury,toxicencephacopathy,epilepsy. Hypohepatia (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, mental disorders, alcohol or medicine addiction.

Fertile woman without contraceptives. Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.

Allergic to or have contraindication to the intervention drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dapagliflozin
12 weeks of Dapagliflozin(10mg/day) treatment, randomly
Drug: Dapagliflozin
Near infrared detection of brain function in diabetic patient at baseline and after 12 weeks of Dapagliflozin(10mg/day) treatment
EXPERIMENTAL: Metformin
12 weeks of Metformin (1500-2000mg/day) treatment, randomly
Drug: Metformin
Near infrared detection of brain function in diabetic patient at baseline and after 12 weeks of Metformin (1500-2000mg/day) treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of cognitive function assessed by cognitive function scale after 12 weeks
Time Frame: Baseline,12 weeks
Baseline,12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (ACTUAL)

March 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESCDP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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