Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/08/2007
Date assigned
03/09/2007
Last edited
10/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Atkin

ORCID ID

Contact details

Michael White Diabetes Centre
Hull Royal Infirmary
220-236 Analby Road
Hull
HU3 2JZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Hull and East Yorkshire Hospital NHS Trust, Research and Development Department - R0066

Study information

Scientific title

Acronym

SAT - Simvastatin and Atorvastatin Therapy

Study hypothesis

The biological variability for lipids is less after atorvastatin therapy compared to simvastatin. Therefore, to consistently achieve a target cholesterol of 5.0 mmol/L the levels will have to be reudced further with simvastatin than with atorvastatin, in orderto account for the increased variability of cholesterol found with the former.

Ethics approval

South Humber Local Research Ethics Commitee (ref: 04/Q1105/40)

Study design

Non-randomised controlled cross-over study.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Type 2 diabetes, hypercholestrolemia

Intervention

All participants were on stable doses of medications (i.e. either atorvastatin 10 mg or simvastatin 40 mg) for at least 3 months. Biological variations of Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C), triglycerides, high sensitivity C-reactive protein (hsCRP), Vitamin D levels and oxidative stress markers were assessed by measuring 12-hour fasting blood samples at four-day intervals on 10 consecutive occasions. Thereafter the patients on simvastatin were changed to atorvastatin 10 mg and vice versa. After 3 months, the biological variation of lipid parameters, hsCRP, Vitamin D levels and oxidative stress markers were assessed again by measuring fasting blood samples at four-day intervals on 10 consecutive occasions in these patients.

Intervention type

Drug

Phase

Not Specified

Drug names

simvastatin , atorvastatin

Primary outcome measures

Biological variability of TC and LDL-C (see Interventions for timepoints of measurement).

Secondary outcome measures

Biological variation of triglycerides and hsCRP (see Interventions for timepoints of measurement).

Overall trial start date

01/02/2005

Overall trial end date

01/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Type 2 diabetes on either atorvastatin 10 mg or simvastatin 40 mg.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Not on concomitant fibrate or additional lipid lowering therapy
2. Inadequately treated hypothyroidism
3. Nephrotic syndrome

Recruitment start date

01/02/2005

Recruitment end date

01/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Michael White Diabetes Centre
Hull
HU3 2JZ
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospitals NHS trust (UK)

Sponsor details

c/o Mrs Nina Dunham
Research and Development Manager
Castle Hill Hospital
Castle Road
Cottingham
East Yorkshire
Hull
HU16 5JQ
United Kingdom

Sponsor type

Government

Website

http://www.hey.nhs.uk/

Funders

Funder type

University/education

Funder name

University of Hull (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18959603

Publication citations

  1. Results

    Sathyapalan T, Atkin SL, Kilpatrick ES, Variability of lipids in patients with Type 2 diabetes taking statin treatment: implications for target setting., Diabet. Med., 2008, 25, 8, 909-915, doi: 10.1111/j.1464-5491.2008.02519.x.

Additional files

Editorial Notes