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The Effects of Some Antihyperglycemic Drugs on Cognitive Function and Risk of Depression of Diabetic Patients (MCI)

B

Beni-Suef University

Status

Enrolling

Conditions

MCI

Treatments

Drug: Control group
Drug: DPP4 Is+metformin
Drug: SGLT2 Is+METFORMIN

Study type

Observational

Funder types

Other

Identifiers

NCT07244770
BeniSuef University Hospital

Details and patient eligibility

About

The study aims to investigate the effects of DPP-4 Is+ metformin versus SGLT2 Is + metformin on the risk of cognitive decline and depression in patients with T2DM.

Full description

Older people suffering from Type 2 Diabetes Mellitus possess a major risk for age related cognitive dysfunction and dementia, mainly due to vascular complications.

SGLT2 inhibitors and DPP4 inhibitors are antidiabetic medications, have shown promise not only in glycemic control but also in potentially mitigating cognitive decline and depressive symptoms.

Enrollment

300 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

-

The study participants should meet the following inclusion criteria:

  1. T2DM adult subjects (>55 years old) will be eligible to participate.
  2. Patients should be taking SGLT2Is+metformin or DDP4Is + metformin for at least 1 year to be eligible.

Exclusion criteria

1- Those with type1 diabetes or ketoacidosis, insulin therapy, end organ failure as chronic renal failure, liver, and heart failure, previous history of pancreatitis, history of Alzheimer's disease or any brain insult, and finally pregnant or lactating females will be excluded from the study.

Trial design

300 participants in 3 patient groups

SGLT2 I Group
Description:
T2DM patients given SGLT2 Is + metformin added to standard of care
Treatment:
Drug: SGLT2 Is+METFORMIN
DPP4I group
Description:
T2DM patients given DPP4Is + metformin added to standard of care
Treatment:
Drug: DPP4 Is+metformin
Control group
Description:
T2DM patients given conventional therapy only
Treatment:
Drug: Control group

Trial contacts and locations

1

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Central trial contact

Asmaa Abdelfattah

Data sourced from clinicaltrials.gov

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