Effect of drug rosuvastatin in females with type 2 diabetes mellitus

Effect of rosuvastatin on the anti-atherogenic effect of high density lipoprotein in pre and post menopausal women with type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/07/014844

Enrollment

Registered

2018-07-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus

Interventions

Intervention1: Rosuvastatin: Rosuvastatin 20mg/day given once daily, orally for 3 months Control Intervention1: Not applicable: As we do not have comparator agent involved in the study and it is singl

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed female patients with Type 2 Diabetes Mellitus aged between 40-70 years as per the revised ADA criteria (47):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 will be included. Patients will be eligible of high intensity statin therapy as per ACC/AHA guidelines 2013 (48) i.e both LDL Cholesterol >75 mg/dL and A 10 year cardiovascular risk score = 7.5% on pooled cohort equation

Exclusion criteria

Exclusion criteria: Male 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 Those on hormone replacement therapy Liver and kidney diseases Other inflammatory diseases Acute illness Malignancy Alcoholics Current smoking On cholesterol lowering drugs Pregnant and lactating women Individuals who are not willing to participate

Design outcomes

Primary

Measure	Time frame
Determine the anti-atherogenic effects of rosuvastatin namely its anti-oxidant and anti-inflammatory effects in pre and post menopausal women patients with type 2 diabetes mellitusTimepoint: 2	—

Secondary

Measure	Time frame
To study lipid lowering effects of rosuvastatin on lipoproteins in pre and post menopausal women with type 2 diabetes mellitus by assessment of lipid profile before and after 12 weeks of Rosuvastatin treatmentTimepoint: 2	—

Countries

India

Contacts

Public ContactAparna R Bitla

SVIMS University

aparnabitla@yahoo.co.in9493547664

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026