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

Primary Purpose

Diabetes Mellitus, Type 2, Cognitive Functions Confusion

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Dapagliflozin
Metformin
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes mellitus, Cognitive Functions, Sodium glucose transporter

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The third hospital affiliated to the Army Medical UniversityRecruiting
  • Zhiming ZhuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dapagliflozin

Metformin

Arm Description

12 weeks of Dapagliflozin(10mg/day) treatment, randomly

12 weeks of Metformin (1500-2000mg/day) treatment, randomly

Outcomes

Primary Outcome Measures

Changes of cognitive function assessed by cognitive function scale after 12 weeks

Secondary Outcome Measures

Full Information

First Posted
March 9, 2020
Last Updated
March 9, 2020
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04304261
Brief Title
Effects of SGLT2i on the Cognitive Function in T2DM Patient (ESCDP)
Acronym
ESCDP
Official Title
Effects of Sodium-glucose Co-transporter-2 Inhibitors on the Cognitive Function in Type 2 Diabetic Patient
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Cognitive Functions Confusion
Keywords
Diabetes mellitus, Cognitive Functions, Sodium glucose transporter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Description
12 weeks of Dapagliflozin(10mg/day) treatment, randomly
Arm Title
Metformin
Arm Type
Experimental
Arm Description
12 weeks of Metformin (1500-2000mg/day) treatment, randomly
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Near infrared detection of brain function in diabetic patient at baseline and after 12 weeks of Dapagliflozin(10mg/day) treatment
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Near infrared detection of brain function in diabetic patient at baseline and after 12 weeks of Metformin (1500-2000mg/day) treatment
Primary Outcome Measure Information:
Title
Changes of cognitive function assessed by cognitive function scale after 12 weeks
Time Frame
Baseline,12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The third hospital affiliated to the Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yingsha, MD
Phone
13594659454
Ext
68
Email
yslimiss@163.com
First Name & Middle Initial & Last Name & Degree
Zhu Zhiming, MD
Facility Name
Zhiming Zhu
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiming Zhu, Doctor
Phone
02368757849
Email
zhuzm@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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