The Effects of Some Antihyperglycemic Drugs on Cognitive... | NCT07244770

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

NCT07244770

Sponsor

Beni-Suef University

Status

Recruiting

Last Update Posted

Jan 30, 2026Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Interventions

SGLT2 Is+METFORMIN
DPP4 Is+metformin
Control group

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Jan 9, 2025

First Submission Date that Met QC Criteria

Nov 20, 2025

First Posted Date

Nov 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2026

Last Update Posted Date

Jan 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SGLT2 Is+METFORMIN	Drug	Patients administering SGLT2 Is+metformin added to their treatment for at least the past 12 months	SGLT2 I Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

T2DM patients (aged above 55 years)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Asmaa Abdelfattah	Contact	002-01095727201		asmaa_abdelfattah86@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beni Suef Hospital	Recruiting	Banī Suwayf			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided