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 |
| Secondary identifying numbers | Hull and East Yorkshire Hospital NHS Trust, Research and Development Department - R0066 |
- 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
Not provided at time of registration
Contact information
Prof Stephen Atkin
Scientific
Scientific
Michael White Diabetes Centre
Hull Royal Infirmary
220-236 Analby Road
Hull
HU3 2JZ
United Kingdom
Study information
| Study design | Non-randomised controlled cross-over study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | South Humber Local Research Ethics Commitee (ref: 04/Q1105/40) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | simvastatin , atorvastatin |
| Primary outcome measure | 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 study start date | 01/02/2005 |
| Overall study end date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 20 |
| Participant inclusion criteria | Type 2 diabetes on either atorvastatin 10 mg or simvastatin 40 mg. |
| 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
- England
- United Kingdom
Study participating centre
Michael White Diabetes Centre
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
Sponsor information
Hull and East Yorkshire Hospitals NHS trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Mrs Nina Dunham
Research and Development Manager
Castle Hill Hospital
Castle Road
Cottingham
East Yorkshire
Hull
HU16 5JQ
England
United Kingdom
| Website | http://www.hey.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
University/education
University of Hull (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
