Health Condition 1: null- Psoriasis with metabolic syndrome
Conditions
Interventions
Intervention1: Metformin: Metformin 1000 mg OD orally,in topical arm for 3 months. Metformin 1000 mg OD orally, in systemic arm for 3 months.
Intervention2: Pioglitazone: Pioglitazone 30 mg OD orally,
Sponsors
PGIMER
Eligibility
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the prevalence of metabolic syndrome in a case control study in psoriasis patients.Timepoint: After complete enrollment of patients | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in individual parameters of metabolic syndrome from baseline after 12 weeks of treatment with metformin, pioglitazone or placebo.Timepoint: After 12 weeks;The change in Physician Global Assessment from baseline to end of treatment in the three treatment groups.Timepoint: After 12 weeks;The changes in the levels of IL -6 and TNF-alpha after 12 weeks of treatment with the study medications or placebo in subgroup of patients.Timepoint: After 12 weeks;The median change in PASI and ESI score from baseline after 12 weeks of treatment with the study medications or placebo when given along with standard treatment for psoriasis in patients whose metabolic syndrome showed improvement versus those in which there was no improvement in MSTimepoint: After 12 weeks;The median change in PASI or ESI scores from baseline after 12 weeks of study treatment given along with standard treatment for psoriasis.Timepoint: After 12 weeks;The number of parameters of metabolic syndrome improved following 12 weeks of treatment with metformin, pioglitazone or placebo.Timepoint: After 12 weeks;The percentage of patients achieving 75% reduction in PASI scores in the three treatment groups.Timepoint: After 12 weeks | — |
Countries
India
Contacts
Public ContactDr Surjit Singh
PGIMER
Outcome results
None listed