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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Impairment
• Intervention / Treatment: Drug: Control group; Drug: DPP-4 inhibitor group; Drug: DPP-4 inhibitor + metformin group

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)

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Asmaa Elsayed; Phone Number: +201095727201; Email: asmaa.abdelfattah@pharm.sohag.edu.eg
• Study Contact Backup: Name: Engy Wahsh; Email: engywahsh@o6u.edu.eg

Study Locations

• Egypt
  • Minya, Egypt, 82511
    • Minia University Hospital
    • Contact: Asmaa Elsayed; Phone Number: +201095727201; Email: asmaa.abdelfattah@pharm.sohag.edu.eg
    • Sub-Investigator: Engy Wahsh, Ph.D.
    • Sub-Investigator: Shireen Riad, Ph.D.
    • Sub-Investigator: Asmaa Mohamed, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; 35 patients will be given placebo (only adjust their drugs to control blood glucose level)	Drug: Control group; 35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level)
Experimental: DPPI Group; 35 T2DM patients will be given DPP4Is once or twice daily	Drug: DPP-4 inhibitor group; 35 T2DM patients will be given DPP-4 I once or twice daily
Experimental: DPPI + metformin group; 35 T2DM patients will be given DPP4Is + metformin once or twice daily	Drug: DPP-4 inhibitor + metformin group; 35 T2DM patients will be given DPP-4 I + metformin once or twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Inflammatory mediators; TNF-α	ELISA kits	Before and post 6 month of treatment
MMSE score	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	Before and post 6 month of treatment
PHQ-9	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.;	Before and post 6 month of treatment
serum amyloid-β		Before and post 6 month of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Collaborators: Faculty of Medicine, Minia University; Clinical Pharmacy Department, Faculty of Pharmacy, 6 October University

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Diabetes; Cognitive; DPP-4 inhibitors
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Metformin; Dipeptidyl-Peptidase IV Inhibitors
• Other Study ID Numbers: BeniSuefU2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No