The Effects of DPPIs on Cognitive Function of Diabetic Patients

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

Detailed Description
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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)

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

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Drug: Control group
* Drug: DPP-4 inhibitor group
* Drug: DPP-4 inhibitor + metformin group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Cognitive, DPP-4 inhibitors, Diabetes