The Effects of Some Antihyperglycemic Drugs on Cognitive Function and Risk of Depression of Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Beni-Suef University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- MCI
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SGLT2 I Group
T2DM patients given SGLT2 Is + metformin added to standard of care
Intervention: SGLT2 Is+METFORMIN (Drug)
DPP4I group
T2DM patients given DPP4Is + metformin added to standard of care
Intervention: DPP4 Is+metformin (Drug)
Control group
T2DM patients given conventional therapy only
Intervention: Control group (Drug)
Outcomes
Primary Outcomes
MCI
Time Frame: Day 1
Changes in Montreal Cognitive Assessment (MoCA) score
Depression
Time Frame: Day 1
Changes in Patient Health Questionnaire-9 (PHQ-9) score
Secondary Outcomes
No secondary outcomes reported
Investigators
Asmaa Abdelfattah Elsayed
Lecturer of clinical pharmacy
Beni-Suef University