Determination of whether the biological variation of fasting lipids differs between simvastatin and atorvastatin therapy in patients with type 2 diabetes: implications for treating to target

ISRCTN	ISRCTN73479504
DOI	https://doi.org/10.1186/ISRCTN73479504
Protocol serial number	Hull and East Yorkshire Hospital NHS Trust, Research and Development Department - R0066
Sponsor	Hull and East Yorkshire Hospitals NHS trust (UK)
Funder	University of Hull (UK)

Submission date: 16/08/2007
Registration date: 03/09/2007
Last edited: 10/05/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stephen Atkin
Scientific

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

Study information

Primary study design	Interventional
Study design	Non-randomised controlled cross-over study.
Secondary study design	Non randomised controlled trial
Scientific title
Study acronym	SAT - Simvastatin and Atorvastatin Therapy
Study objectives	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(s)	South Humber Local Research Ethics Commitee (ref: 04/Q1105/40)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	simvastatin , atorvastatin
Primary outcome measure(s)	Biological variability of TC and LDL-C (see Interventions for timepoints of measurement).
Key secondary outcome measure(s)	Biological variation of triglycerides and hsCRP (see Interventions for timepoints of measurement).
Completion date	01/02/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	20
Key inclusion criteria	Type 2 diabetes on either atorvastatin 10 mg or simvastatin 40 mg.
Key exclusion criteria	1. Not on concomitant fibrate or additional lipid lowering therapy 2. Inadequately treated hypothyroidism 3. Nephrotic syndrome
Date of first enrolment	01/02/2005
Date of final enrolment	01/02/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Michael White Diabetes Centre

Hull
HU3 2JZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2008		Yes	No