The Effects of DPPIs on Cognitive Function of Diabetic Patients

Beni-Suef University

Status and phase: Not yet enrolling; Phase 4

Conditions: Cognitive Impairment

Treatments: Drug: DPP-4 inhibitor + metformin group; Drug: Control group; Drug: DPP-4 inhibitor group

Study type: Interventional

Funder types: Other

Identifiers

NCT06164535

BeniSuefU2023

Details and patient eligibility

About

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

Full 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)

Enrollment: 105 estimated patients

Sex: All

Ages: 45 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Control group

DPPI Group

Experimental group

Description:

35 T2DM patients will be given DPP4Is once or twice daily

Treatment:

Drug: DPP-4 inhibitor group

DPPI + metformin group

Experimental group

Description:

35 T2DM patients will be given DPP4Is + metformin once or twice daily

Treatment:

Drug: DPP-4 inhibitor + metformin group