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

January 28, 2026 updated by: Asmaa Abdelfattah Elsayed, Beni-Suef University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Banī Suwayf, Egypt
        • Recruiting
        • Beni suef hospital
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

T2DM patients (aged above 55 years)

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SGLT2 I Group
T2DM patients given SGLT2 Is + metformin added to standard of care
Drug: SGLT2 Is+METFORMIN
Patients administering SGLT2 Is+metformin added to their treatment for at least the past 12 months
Other Names:
  • Group 1
DPP4I group
T2DM patients given DPP4Is + metformin added to standard of care
Drug: DPP4 Is+metformin
Patients administering DPP4 I+ metformin added to their treatment for at least the past 12 months
Other Names:
  • Group 2
Control group
T2DM patients given conventional therapy only
Drug: Control group
patients administered their standard of care without any changes for the past 6 months
Other Names:
  • Group 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MCI
Time Frame: Day 1
Changes in Montreal Cognitive Assessment (MoCA) score
Day 1
Depression
Time Frame: Day 1
Changes in Patient Health Questionnaire-9 (PHQ-9) score
Day 1

Collaborators and Investigators

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

Sponsor

Beni-Suef 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 (Actual)

January 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeniSuef University Hospital

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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