Effect of Atorvastatin on Glycemic Control in Prediabetic Patients

August 14, 2015 updated by: Dr. Sansita Parida, Shri Ramachandra Bhanj Medical College
The study was conducted to find out any possible effect of Atorvastatin on glycemic parameters in prediabetic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetes is a growing public health problem throughout the world, threatening global health and economic prosperity. Currently, approximately 171 to 194 million people in the world have diabetes, the majority of the cases being Type II. This number is expected to increase to more than 330 million by the year 2025-a record doubling within a single generation. India with 62.2 million diabetic patients is fast becoming the diabetes capital of the world with possibility of the number of diabetic patients reaching the 80 million mark by 2030. Every sixth diabetic in the world is an Indian. China with 43.2 million patients comes second, followed by the US where 26.8 million people suffer from the disease.

This spectacular increase in the frequency of Type II diabetes is being paralleled by a similarly alarming increase in obesity, which is one of the major risk factors for Type II diabetes. Because of the close linkage of these two conditions, Ziv and Shafrir have suggested the term "diabesity" to describe this association. This dual epidemic which was largely ignored by the public health community until recently has come as a great surprise involving enormous economic burden as well as in terms of health. Disorders of glucose metabolism are associated with increased risk for cardiovascular disease (CVD) complications, including coronary, peripheral and cerebral arterial disease, that account for the majority of morbidity and mortality among patients with diabetes mellitus (DM).

Type II diabetes is commonly associated with dyslipidaemia, which represents a synergistic risk factor for cardiovascular disease. The National Cholesterol Education Program Adult Treatment Panel III (ATP III) listed diabetes as a coronary heart disease (CHD) risk equivalent for setting therapeutic goals for LDL cholesterol. A goal for LDL cholesterol of <100 mg/dl was recommended for patients with CHD and CHD risk equivalents. For the majority of patients with diabetes, this LDL cholesterol goal would evoke the use of cholesterol-lowering drugs, particularly statins. Some Interventional studies emphasized that statin treatment leads to a reduction in cardiovascular events independent of lipid reduction with possible benefits for patients with Type II diabetes. Statins could also contribute to diabetes prevention owing to lipid-lowering and so-called pleiotropic action. Statins improve endothelial function, inhibit smooth muscle cell proliferation, and reduce oxidative stress and inflammation. Thus, with recent FDA approved indications for statins being widened, statins are currently amongst the most widely used drugs in patients with or without diabetes.

Although statin therapy reduces cardiovascular risk, its relationship with the development of diabetes is controversial. Retrospective analysis of the West of Scotland Coronary Prevention Study (WOSCOPS) revealed that 5 years of treatment with pravastatin reduced diabetes incidence by 30%. The authors suggested that although lowering of triglyceride levels could influence diabetes incidence, other mechanisms such as anti-inflammatory action may be involved. On the contrary, pravastatin did not decrease diabetes incidence in another trial including glucose-intolerant humans, suggesting that early inception of statin therapy may be required for effective diabetes prevention. Likewise, simvastatin did not affect diabetes incidence in patients with atherosclerosis in the Heart Protection Study. In contrast, atorvastatin marginally increased diabetes incidence in the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT-LLA), which could be explained by statistical variation.

A recent review of 13 studies by Naveed Sattar, et al. published in The Lancet in 2010, on statins and their side-effects including a total of more than 91,140 participants suggested that use of statins is associated with increased risk of Type II diabetes by 9%.

However researchers of this meta-analysis have stressed that this study does not prove that statins directly raise the risk of Type II diabetes, but it raises the possibility of either a direct or indirect link between statins and diabetes that merits further investigation. Thus, exploring the role of statins in the initiation or progression of diabetes mellitus is an exciting area for investigation.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Odisha
      • Cuttack, Odisha, India, 752001
        • SCB Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population was selected from patients attending Cardiology and Medicine Outpatient Department of S.C.B. Medical College, Cuttack, following inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • Any patient on statins therapy whose blood sugar level is within normal limit.
  • Pre-diabetic patients (IFG and/or IGT) on statins
  • Patients who agreed to participate in the study and signed the informed consent form without any external motivation

Exclusion Criteria:

  • Diagnosed cases of DM, both type I and II, on different anti-diabetic regimen
  • Patients on β-blockers, thiazide diuretics, corticosteroids, which can affect blood sugar level
  • Pregnancy and lactation
  • Co-existing or other organ involvement like kidney, liver which can affect blood sugar level

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normoglycemic group
25 patients were recruited who were on Atorvastatin and with normal blood glucose and Hb1Ac level.
Drug: Atorvastatin
Some patients were receiving 20 mg of Atorvastatin wheras others were on a higher dose of 40-80mg daily. Patients were taking statins for either dyslipidemia, or primary or secondary prevention of cardiovascular disease.
Prediabetic with normal GTT
25 patients were recruited who were on Atorvastatin and with fasting blood sugar level 100-125 mg/dl with normal GTT.
Drug: Atorvastatin
Some patients were receiving 20 mg of Atorvastatin wheras others were on a higher dose of 40-80mg daily. Patients were taking statins for either dyslipidemia, or primary or secondary prevention of cardiovascular disease.
Prediabetic with impaired GTT
25 patients were recruited who were on Atorvastatin and with fasting blood sugar level 100-125 mg/dl with impaired GTT.
Drug: Atorvastatin
Some patients were receiving 20 mg of Atorvastatin wheras others were on a higher dose of 40-80mg daily. Patients were taking statins for either dyslipidemia, or primary or secondary prevention of cardiovascular disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Glycosylated Hemoglobin (HbA1c) from baseline
Time Frame: At baseline and at 6 monhts, 12 months and 18 months follow up
At baseline and at 6 monhts, 12 months and 18 months follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Fasting blood sugar from baseline
Time Frame: At baseline and at 6 monhts, 12 months and 18 months follow up
At baseline and at 6 monhts, 12 months and 18 months follow up
Change in Post prandial blood sugar from baseline
Time Frame: At baseline and at 6 monhts, 12 months and 18 months follow up
At baseline and at 6 monhts, 12 months and 18 months follow up
Lipid profile
Time Frame: At baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shri Ramachandra Bhanj Medical College

Investigators

  • Study Director: TRUPTI R SWAIN, MD, SCB Medical College, Cuttack, Odisha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (ESTIMATE)

June 12, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 14, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC/SCB/Pharma/2011/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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