The Effects of DPPIs on Cognitive Function of Diabetic Patients

Phase 4

Not yet recruiting

• Conditions: Cognitive Impairment
• Interventions: Drug: Control group; Drug: DPP-4 inhibitor group; Drug: DPP-4 inhibitor + metformin group

• Registration Number: NCT06164535
• Lead Sponsor: Beni-Suef University

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)

Study Timeline

• Study First Submitted: 2023-11-30
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11
• Study Start: 2023-12-30
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control group	35 patients will be given placebo (only adjust their drugs to control blood glucose level)
DPPI Group	DPP-4 inhibitor group	35 T2DM patients will be given DPP4Is once or twice daily
DPPI + metformin group	DPP-4 inhibitor + metformin group	35 T2DM patients will be given DPP4Is + metformin once or twice daily

Primary Outcome Measures

Name	Time	Method
serum amyloid-β	Before and post 6 month of treatment
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 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

Secondary Outcome Measures

Name	Time	Method
Serum fasting and 2-he post prandial glucose	Before and post 6 month of treatment
Serum Insulin	Before and post 6 month of treatment	ElISA kits
HOMA-IR	Before and post 6 month of treatment

Trial Locations

Locations (1)

Minia University hospital; 🇪🇬 Minya, Egypt