The Effects of DPPIs on Cognitive Function of Diabetic Patients

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06164535
• Other study ID #: BeniSuefU2023
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 30, 2023
• Est. completion date: July 15, 2024

Study information

• Verified date: December 2023
• Source: Beni-Suef University
• Contact: Asmaa Elsayed
• Phone: +201095727201
• Email: asmaa.abdelfattah[@]pharm.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: July 15, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Drug:
• Control group
35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level)
• DPP-4 inhibitor group
35 T2DM patients will be given DPP-4 I once or twice daily
• DPP-4 inhibitor + metformin group
35 T2DM patients will be given DPP-4 I + metformin once or twice daily

Locations

Country	Name	City	State
Egypt	Minia University hospital	Minya

Sponsors (3)

Lead Sponsor	Collaborator
Beni-Suef University	Clinical Pharmacy Department, Faculty of Pharmacy, 6 October University, Faculty of Medicine, Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Inflammatory mediators; TNF-a	ELISA kits	Before and post 6 month of treatment
Primary	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
Primary	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
Primary	serum amyloid-ß		Before and post 6 month of treatment
Secondary	Serum Insulin	ElISA kits	Before and post 6 month of treatment
Secondary	Serum fasting and 2-he post prandial glucose		Before and post 6 month of treatment
Secondary	HOMA-IR		Before and post 6 month of treatment