The Effects of DPPIs on Cognitive Function of Diabetic Patients

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06164535

Enrollment

105

Registered

2023-12-11

Start date

2023-12-30

Completion date

2024-07-15

Last updated

2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment

Keywords

Cognitive, DPP-4 inhibitors, Diabetes, Depression

Brief summary

This is a single-center, randomized controlled clinical trial with a parallel-group design conducted at Minia University hospital.

Detailed description

All patients admitted to Diabetes clinics of Minia University Hospital, will be screened for the eligibility criteria. diabetic patients (aged above 50 years) with uncontrolled diabetes on oral hypoglycemic drugs. 105 patients will be enrolled and randomized into three groups. Group I=35 T2DM patients given DPP4Is Group II=35 T2DM patients given DPP4Is and metformin. Group III=35 patients will be given placebo (only adjust their drugs to control blood glucose level)

Interventions

DRUGControl group

35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level)

DRUGDPP-4 inhibitor group

35 T2DM patients will be given DPP-4 I once or twice daily

DRUGDPP-4 inhibitor + metformin group

35 T2DM patients will be given DPP-4 I + metformin once or twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Masking description

all patient information will be anonymized giving only corresponding numbers, which will be revealed by the PI after assessment.

Eligibility

Sex/Gender

ALL

Age

45 Years to 60 Years

Healthy volunteers

Inclusion criteria

Type-2 diabetic adult subjects (above 50 years old) who had uncontrolled (A1c=8-9 %) blood glucose levels with an oral hypoglycemic drug at the screening visit were eligible to participate.

Exclusion criteria

Those with type1 diabetes or ketoacidosis, end organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female), liver cell failure (elevated alanine transaminase (ALT) and aspartate transaminase (AST) ≥ 2 folds), and heart failure, previous history of pancreatitis, and pregnant or lactating females were excluded from the study.

Design outcomes

Primary

Measure	Time frame	Description
Serum Inflammatory mediators; TNF-α	Before and post 6 month of treatment	ELISA kits
MMSE score	Before and post 6 month of treatment	Validated questionnaire assessing the Estimation of Mini Mental State The MMSE has a maximum score of 30 points. The scores are generally grouped as follows: 25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia Examination (MMSE) score
PHQ-9	Before and post 6 month of treatment	Validated questionnaire assessing patient mental health and depression PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.;
serum amyloid-β	Before and post 6 month of treatment	—

Secondary

Measure	Time frame	Description
Serum fasting and 2-he post prandial glucose	Before and post 6 month of treatment	—
HOMA-IR	Before and post 6 month of treatment	—
Serum Insulin	Before and post 6 month of treatment	ElISA kits

Countries

Egypt

Contacts

Primary ContactAsmaa Elsayed

asmaa.abdelfattah@pharm.sohag.edu.eg+201095727201

Backup ContactEngy Wahsh

engywahsh@o6u.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026