NCT02470455

Brief Summary

The study was conducted to find out any possible effect of Atorvastatin on glycemic parameters in prediabetic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

June 4, 2015

Last Update Submit

August 14, 2015

Conditions

Prediabetic State

Keywords

AtorvastatinPrediabeticsHbA1c

Outcome Measures

Primary Outcomes (1)

  • Change in Glycosylated Hemoglobin (HbA1c) from baseline

    At baseline and at 6 monhts, 12 months and 18 months follow up

Secondary Outcomes (3)

  • Change in Fasting blood sugar from baseline

    At baseline and at 6 monhts, 12 months and 18 months follow up

  • Change in Post prandial blood sugar from baseline

    At baseline and at 6 monhts, 12 months and 18 months follow up

  • Lipid profile

    At baseline

Study Arms (3)

Normoglycemic group

25 patients were recruited who were on Atorvastatin and with normal blood glucose and Hb1Ac level.

Drug: Atorvastatin

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

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

Interventions

AtorvastatinDRUG

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.

Normoglycemic groupPrediabetic with impaired GTTPrediabetic with normal GTT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SCB Medical College

Cuttack, Odisha, 752001, India

Location

Related Publications (7)

  • Cholesterol Treatment Trialists' (CTT) Collaborators; Kearney PM, Blackwell L, Collins R, Keech A, Simes J, Peto R, Armitage J, Baigent C. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet. 2008 Jan 12;371(9607):117-25. doi: 10.1016/S0140-6736(08)60104-X.

    PMID: 18191683RESULT

  • Forrester JS, Libby P. The inflammation hypothesis and its potential relevance to statin therapy. Am J Cardiol. 2007 Mar 1;99(5):732-8. doi: 10.1016/j.amjcard.2006.09.125. Epub 2007 Jan 10.

    PMID: 17317382RESULT

  • Freeman DJ, Norrie J, Sattar N, Neely RD, Cobbe SM, Ford I, Isles C, Lorimer AR, Macfarlane PW, McKillop JH, Packard CJ, Shepherd J, Gaw A. Pravastatin and the development of diabetes mellitus: evidence for a protective treatment effect in the West of Scotland Coronary Prevention Study. Circulation. 2001 Jan 23;103(3):357-62. doi: 10.1161/01.cir.103.3.357.

    PMID: 11157685RESULT

  • Keech A, Colquhoun D, Best J, Kirby A, Simes RJ, Hunt D, Hague W, Beller E, Arulchelvam M, Baker J, Tonkin A; LIPID Study Group. Secondary prevention of cardiovascular events with long-term pravastatin in patients with diabetes or impaired fasting glucose: results from the LIPID trial. Diabetes Care. 2003 Oct;26(10):2713-21. doi: 10.2337/diacare.26.10.2713.

    PMID: 14514569RESULT

  • Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16.

    PMID: 20167359RESULT

  • Fisslthaler B, Michaelis UR, Randriamboavonjy V, Busse R, Fleming I. Cytochrome P450 epoxygenases and vascular tone: novel role for HMG-CoA reductase inhibitors in the regulation of CYP 2C expression. Biochim Biophys Acta. 2003 Feb 17;1619(3):332-9. doi: 10.1016/s0304-4165(02)00492-0.

    PMID: 12573493RESULT

  • Moosmann B, Behl C. Selenoprotein synthesis and side-effects of statins. Lancet. 2004 Mar 13;363(9412):892-4. doi: 10.1016/S0140-6736(04)15739-5.

    PMID: 15031036RESULT

MeSH Terms

Conditions

Prediabetic State

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • TRUPTI R SWAIN, MD

    SCB Medical College, Cuttack, Odisha

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 12, 2015

Study Start

July 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

IN(1)