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Effect of the drug Rosuvastatin in lowering the risk of heart disease in diabetes patients

Phase 4
Completed
Conditions
Health Condition 1: null- Type 2 Diabetes Mellitus patients
Registration Number
CTRI/2017/09/009695
Lead Sponsor
Sri Venkateswara Institute of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

Newly diagnosed male patients with T2DM aged between 40-70 years as per the revised ADA criteria (37):i.e

i) Fasting plasma glucose =126mg/dL (7.0mmol/L)

ii) 2 hour plasma glucose =200mg/dL (11.1mmol/L)

iii) Glycosylated hemoglobin (HbA1c) >6.5% (48 mmol/mol)

Patients with T2DM on oral antidiabetic treatment and with LDL levels > 75 mg/dl will be included.

Exclusion Criteria

Female patients with type 2 Diabetes mellitus

Patients with other forms of Diabetes (T1DM, Gestational diabetes mellitus)

Those on insulin therapy

Thyroid disorders not on treatment

Those on pioglitazone

Liver and kidney diseases

Other inflammatory diseases

Acute illness

Malignancy

Alcoholics

Current smoking

On cholesterol lowering drugs

Individuals who are not willing to participate

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Determine the anti-atherogenic effects of rosuvastatin namely its anti-oxidant and anti-inflammatory effects in patients with type 2 diabetes mellitusTimepoint: 2
Secondary Outcome Measures
NameTimeMethod
Determine the lipid lowering capacity of rosuvastatin by assessment of lipid profile in patients with T2DM before and after 12 weeks of Rosuvastatin treatmentTimepoint: 2
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