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

Phase 2

Completed

• Conditions: Health Condition 1: null- Psoriasis with metabolic syndrome

• Registration Number: CTRI/2011/12/002252
• Lead Sponsor: PGIMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 98

Inclusion Criteria

Psoriasis requiring topical or systemic therapy.

Metabolic syndrome ie. the presence of three or more criteria of the modified National Cholesterol Education Program�s 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.

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the prevalence of metabolic syndrome in a case control study in psoriasis patients.Timepoint: After complete enrollment of patients