PREVALENCE OF METABOLIC SYNDROME IN PSORIASIS PATIENTS AND EVALUATION OF SAFETY AND EFFICACY OF INSULIN SENSITIZERS (METFORMIN AND PIOGLITAZONE) ON METABOLIC SYNDROME IN THESE PATIENTS IN RANDOMISED OPEN LABEL PLACEBO CONTROL TRIA

PGIMER0 个研究点目标入组 98 人开始时间: 待定最近更新: 2021年11月24日

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•Psoriasis requiring topical or systemic therapy.
•Metabolic syndrome ie. the presence of three or more criteria of the modified National Cholesterol Education Programï¿½s Adult Treatment Panel III ( NCEP ATP III:
•(i)waist circumference 90 cm in men and 80 cm in women
•(ii)hypertriglyceridemia >= 150 mg/dl
•(iii)high density lipoprotein (HDL) cholesterol 40 mg/dl in males and 50 mg/dl in females
•(iv)blood pressure >= 130/85 mm Hg
•(v)fasting plasma glucose >= 110 mg/dl
•Patients willing to provide written informed consent.

•Patients on topical therapy other than coal tar and systemic therapy other than methotrexate.
•Pregnant or nursing women. Women of childbearing potential will be considered potentially eligible provided they are following barrier method of contraception.
•Patients with significant hepatic impairment (serum bilirubin, AST, ALT and alkaline phosphatase 1.5 times the upper limit of normal).
•Renal insufficiency - serum creatinine >=1.5 mg/dL (men) or >=1.4mg/dL (women).
•Congestive heart failure requiring treatment, acute or chronic metabolic acidosis including diabetic ketoacidosis or any major significantly uncontrolled co-morbidity.
•Known hypersensitivity to metformin. Acute haemodynamic compromise or hypoxic states
•Dehydration
•Use of iodinated contrast for radiological examinations (withdraw on the day of and for 48h after the procedure; restart metformin once normal renal function is documented).

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