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| Name | Class |
|---|---|
| October 6 University | OTHER |
| Minia University | OTHER |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | 35 patients will be given placebo (only adjust their drugs to control blood glucose level) |
|
| DPPI Group | Experimental | 35 T2DM patients will be given DPP4Is once or twice daily |
|
| DPPI + metformin group | Experimental | 35 T2DM patients will be given DPP4Is + metformin once or twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group | Drug | 35 T2DM patients will be given placebo (only adjust their drugs to control blood glucose level) |
|
| 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 |
| 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 |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asmaa Elsayed | Contact | +201095727201 | asmaa.abdelfattah@pharm.sohag.edu.eg | |
| Engy Wahsh | Contact | engywahsh@o6u.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia University hospital | Minya | 82511 | Egypt |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003920 | Diabetes Mellitus |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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all patient information will be anonymized giving only corresponding numbers, which will be revealed by the PI after assessment.
| DPP-4 inhibitor group | Drug | 35 T2DM patients will be given DPP-4 I once or twice daily |
|
| DPP-4 inhibitor + metformin group | Drug | 35 T2DM patients will be given DPP-4 I + metformin once or twice daily |
|
| HOMA-IR | Before and post 6 month of treatment |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D008722 | Methods |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |