Evaluation of the side effects and efficacy of roflumilast on glycemic parameters, insulin resistance, oxidative and inflammatory markers in Type 2 diabetic patients with diabetic neuropathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Administration of alpha-lipoic acid 600mg plus vildagliptin/metformin combination (50/1000mg) orally once daily for 3 months.
Administration of 500 mcg plus vildagliptin/metformin combination(50/1000mg) orally once daily for 3 months.
Asmaa Elshafey Elsharab
Tanta, Egypt
Change in fasting blood glucose
Using glucose oxidase method for assessment of blood glucose and subtracting pre-treatment from post-treatment values
Time frame: baseline and 3 months later
Change in plasma insulin level
Subtracting pre-treatment from post-treatment values of plasma insulin
Time frame: baseline and 3 months later
Change in HOMA-IR index
HOMA-IR will be calculated for all patients at baseline and 3 months later.
Time frame: baseline and 3 months later
Change in HOMA-B index
HOMA-B will be calculated for all patients at baseline and 3 months later.
Time frame: baseline and 3 months later.
Change in HbA1c
Subtracting pre-treatment from post-treatment values of HbA1C
Time frame: baseline and 3 months later
Changes in TNF-alfa serum level
Subtracting pre-treatment from post-treatment values of TNF-alfa.
Time frame: baseline and 3 months later
Changes in malondialdehyde serum level (MDA)
Subtracting pre-treatment from post-treatment values of MDA.
Time frame: baseline and 3 months later
Changes in neurotensin serum levels
Subtracting pre-treatment from post-treatment values of neurotensin serum levels.
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Time frame: baseline and 3 months later
Ewing score
Subtracting pre-treatment from post-treatment changes in summation of the cardiac autonomic reflex tests (CARTs) including heart response to a deep breathing test, changes in immediate heart rate response to standing, and changes in blood pressure response to sustained handgrip testing.
Time frame: baseline and 3 months later
Changes of Michigan Neuropathy Screening Instrument
A 15-item questionnaire (MNSIQ) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers. MNSIQ was designed to screen for diabetic neuropathy through questionnaires on 15 questions that are related to neuropathic symptoms (pain, temperature, and sensation). Two of 15 (number 4 and 10) are vascular symptoms and are excluded from the total score regardless of the results. If you answered 'No' to questions 7 and 13, you will get 1 point. In the end, scores ranging from 0 to 13 indicate that the higher the score, the more severe the neuropathic symptoms.
Time frame: baseline and 3 months later
Changes of Michigan Neuropathy Screening Instrument(MNSIE)
A foot test (MNSIE) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers. MNSIE evaluates foot shape, foot ulceration, ankle reflex, sense of vibration of big toe, monofilament right and left. The score ranges from point 0 to 10, and when the score is above 2, it is diagnosed as neuropathy.
Time frame: baseline and 3 months later
Changes of Douleur Neuropathique-4 (DN4) questionnaire (DN4)
DN4 Neuropathic Pain Diagnostic Questionnaire which reflect positive symptoms for pain ( burning, painful cold, electric shocks, )
Time frame: baseline and 3 months later