This is a single-center, randomized controlled clinical trial with a parallel-group design conducted at Minia University hospital.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
105
35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level)
35 T2DM patients will be given DPP-4 I once or twice daily
35 T2DM patients will be given DPP-4 I + metformin once or twice daily
Minia University hospital
Minya, Egypt
Serum Inflammatory mediators; TNF-α
ELISA kits
Time frame: 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
Time frame: 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.;
Time frame: Before and post 6 month of treatment
serum amyloid-β
Time frame: Before and post 6 month of treatment
Serum Insulin
ElISA kits
Time frame: Before and post 6 month of treatment
Serum fasting and 2-he post prandial glucose
Time frame: Before and post 6 month of treatment
HOMA-IR
Time frame: Before and post 6 month of treatment
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