Effect of Atorvastatin on Glycemic Control in Prediabetic Patients
Information source: Shri Ramachandra Bhanj Medical College
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prediabetic State
Intervention: Atorvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Shri Ramachandra Bhanj Medical College Official(s) and/or principal investigator(s): TRUPTI R SWAIN, MD, Study Director, Affiliation: SCB Medical College, Cuttack, Odisha
Summary
The study was conducted to find out any possible effect of Atorvastatin on glycemic
parameters in prediabetic patients.
Clinical Details
Official title: Effect of Atorvastatin on Glycemic Control in Prediabetic Patients
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Change in Glycosylated Hemoglobin (HbA1c) from baseline
Secondary outcome: Change in Fasting blood sugar from baselineChange in Post prandial blood sugar from baseline Lipid profile
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
SCB Medical College, Cuttack, Odisha 752001, India
Additional Information
Starting date: July 2011
Last updated: August 14, 2015
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