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NCT Number: NCT07244770

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

MCI

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beni Suef Hospital

Banī Suwayf, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-

The study participants should meet the following inclusion criteria:

  • T2DM adult subjects (>55 years old) will be eligible to participate.
  • 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.

Treatment and study plan

SGLT2 Is+METFORMIN

Drug

Patients administering SGLT2 Is+metformin added to their treatment for at least the past 12 months

Other names: Group 1

DPP4 Is+metformin

Drug

Patients administering DPP4 I+ metformin added to their treatment for at least the past 12 months

Other names: Group 2

Control group

Drug

patients administered their standard of care without any changes for the past 6 months

Other names: Group 3

Primary outcomes

  1. MCI

    Time frame: Day 1

    Changes in Montreal Cognitive Assessment (MoCA) score

  2. Depression

    Time frame: Day 1

    Changes in Patient Health Questionnaire-9 (PHQ-9) score

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Acronym: MCI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Jul 24, 2026

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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