Role of metformin in patients having psoriasis and metabolic syndrome

Not Applicable

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

Registration Number: CTRI/2017/12/010801

Lead Sponsor: Post graduate Institute of Medical Education and Research PGIMER Chandigarh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients with stable plaque psoriasis having mild to moderate disease severity not requiring systemic therapy i.e., PASI 1-10 and involvement of <10% of body surface area

2. Metabolic syndrome i.e., the presence of three or more criteria of the Consensus definition for Asian Indians:

(i)Waist circumference > 90 cm in men and > 80 cm in women

(ii) Hypertriglyceridemia > 150 mg/dl

(iii)High density lipoprotein (HDL) cholesterol Men < 40 mg/dl, Women <50 mg/dl.

(iv)Blood pressure > 130/85 mm Hg

(v)Fasting Blood glucose > 100 mg/dl

3. Patients willing to provide written informed consent

Exclusion Criteria

1. Psoriasis patients with severe disease (Involvement of >10% body surface area and PASI > 10)

2. Patients with guttate, erythrodermic, or pustular psoriasis and psoriatic arthritis.

3. Patients receiving systemic treatment.

4. History, clinical findings on current examination indicative of cardiovascular disease.

5. Renal insufficiency - serum creatinine >=1.5 mg/dL (men) or >=1.4mg/dL (women).

6. Patients with significant hepatic impairment (serum bilirubin, AST, ALT and alkaline phosphatase >1.5 times the upper limit of normal).

7. Pregnant or nursing women. Women of childbearing potential will be considered potentially eligible provided they are following barrier method of contraception.

8. Any other chronic medical illness that may jeopardise interpretation of study results

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of metformin on serum YKL-40, Asymmetrical dimethyl arginine (ADMA) and peak Flow Mediated Dilation (FMD).Timepoint: After 12 weeks

Secondary Outcome Measures

Name	Time	Method
To compare the levels of Serum YKL-40, Serum Asymmetrical Dimethyl Arginine and peak Flow Mediated Dilation in psoriasis patients with and without metabolic syndrome and in patients with various dermatosis without metabolic syndrome.Timepoint: After 12 weeks;To evaluate the correlation of markers of endothelial dysfunction with change in Psoriasis Area Severity Index (PASI).Timepoint: After 12 weeks