A clinical trial to study the effect of atorvastatin on pancreatic beta-cell function & insulin resistence in patients with type 2 diabetes mellitus
- Conditions
- Health Condition 1: null- Diabetes Mellitus Type 2 with Hyperlipidemia
- Registration Number
- CTRI/2008/091/000099
- Lead Sponsor
- Department of Pharmacology AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 42
1.Patient with type 2 diabetes mellitus not taking insulin.
2.Patient should not have taken statins during past 3 months.
3.Patients of either sex aged 18 years and above.
4. Patient should not be on more than two anti-diabetic drugs(Sulphonylureas & Biguanides)
5.LDL >99 - <161 mg/dl if patient had received Medical Nutrition Therapy (MNT) earlier at least for three months and LDL >129 - <161 mg/dl if the patient had not received MNT earlier
6.HbA1c >6.4 - <10
1. Patient already taking statin or on insulin therapy
2. Deranged liver function test, renal function test
3. Clinically significant cardiovascular disease including history of myocardial infraction or Heart failure (NYHA class III or IV)
4.Pregnancy
5.Lactation
6.Drug abuse
7.Hypersensitivity to statins
8.Patients on drugs that can increase the incidence of statin induced myopathy
9.Patient on drugs causing hyperglycemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HOMA2 IR and HOMA2 %betaTimepoint: Baseline and at 12 weeks
- Secondary Outcome Measures
Name Time Method Adverse event monitoring in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks;Change in HbA1c in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks;Change in oxidative stress markers in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks;QOL in type 2 diabetes mellitus patients receiving atorvastatinTimepoint: Baseline and at 12 weeks