The effect of statin treatment on mitochondrial function and lipid oxidation
| ISRCTN | ISRCTN97637728 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97637728 |
| Secondary identifying numbers | H-4-2009-095 |
- Submission date
- 28/02/2018
- Registration date
- 21/03/2018
- Last edited
- 24/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Hypercholesterolemia (high cholesterol) is a major risk factor for development of stroke and coronary heart disease. Statins are tablets that lower cholesterol and are the first choice of treatment for high cholesterol; around 10% of the population in the Nordic countries (Denmark, Sweden and Norway) are using statins. However, skeletal muscle pain (myalgia) is reported in up to 30% of patients, ranging from mild pain to rare cases of severe pain and complications in conditions such as rhabdomyolysis. The mechanisms behind the muscle pain are not known, but mitochondrial function (production of energy in cells) could be involved. Furthermore it is not known if lipid oxidation is impaired in patients taking simvastatin.
This study aims to determine if simvastatin treatment is affecting mitochondrial function as well as lipid oxidation.
Who can participate?
1. Males aged 30 – 60 years
2. Males aged 30 – 60 years taking simvastatin for at least 1 year
What does the study involve?
Participants attend the laboratory on two occasions, both following a period of fasting. At the first visit, they have
What are the possible benefits and risks of participating?
Participants will benefit from gaining knowledge of their own clinical parameters such as body composition, glucose homeostasis and cardiorespiratory fitness.
All participants have a muscle sample taken and an oral glucose tolerance test, which are both invasive procedures with a small risk of infection.
Where is the study run from?
University of Copenhagen Xlab (Denmark)
When is the study starting and how long is it expected to run for?
October 2009 – December 2012
Who is funding the study?
1. Danish Council for Independent research-Medical Sciences (Denmark)
2. Nordea Foundation (Denmark)
Who is the main contact?
Mr Steen Larsen (Scientific)
Contact information
Scientific
University of Copenhagen
Panum
Blegdamsvej 3b
Copenhagen
2200
Denmark
 ORCID ID |
0000-0002-5170-4337 |
|---|
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Is mitochondrial function and lipid oxidation impaired in patients treated with simvastatin compared with well matched controls? |
| Study objectives | Mitochondrial function and lipid oxidation is impaired with simvastatin treatment |
| Ethics approval(s) | Ethical committee of Denmark, 09/09/2009, ref: H-4-2009-095 |
| Health condition(s) or problem(s) studied | Mitochondrial function and lipid oxidation |
| Intervention | The study is a cross-sectional study, so there was no intervention. 10 healthy volunteers are recruited, and 10 participants taking simvastatin. Participants are matched for age, activity level, maximal oxygen uptake and obesity because it is known that all these factors influence mitochondrial function and lipid oxidation. All participants come to the laboratory for a screening visit having fasted, at which medical history, blood pressure and body composition are recorded. A resting electrocardiogram, oral glucose tolerance test and maximal oxygen consumption test are also performed. Participants return for an experimental day, again following fasting, where they have a blood sample taken, resting metabolic rate measured, a muscle biopsy, maximal fat oxidation test and maximal oxygen test. |
| Intervention type | Not Specified |
| Primary outcome measure | Mitochondrial function measured by high-resolution respirometry and lipid oxidation (whole body lipid oxidation) and protein analysis at the second visit. |
| Secondary outcome measures | Glucose homeostasis measured using the oral glucose tolerance test at the first visit. |
| Overall study start date | 01/10/2009 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 20 subjects; 10 in the simvastatin treated group and 10 in the control group. |
| Total final enrolment | 20 |
| Key inclusion criteria | Simvastin group 1. Male participants aged 30-60 years 2. Normal kidney and liver function 3. BMI between 25-35 4. Taking simvastatin for at least 1 year 5. Does not have type II Diabetes Control group 1. Male participants aged 30-60 years 2. Normal kidney and liver function 3. BMI between 25-35 4. Does not have type II Diabetes |
| Key exclusion criteria | 1. Must not be taking medication (other than simvastatin). 2. Must not be disposed to type 2 diabetes |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Panum
Blegdamsvej 3b
Copenhagen N
2200
Denmark
Sponsor information
University/education
Xlab
Panum
Blegdamsvej 3b
Copenhagen
2200
Denmark
| Website | http://www.ku.dk/english/ |
|---|---|
"ROR" |
https://ror.org/035b05819 |
Funders
Funder type
Research council
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | The data will be published in relevant international peer reviewed journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository on a secure network drive at the University of Copenhagen. All subjects have a number, so that data is completely anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/09/2018 | 24/01/2020 | Yes | No |
Editorial Notes
24/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
17/01/2020: Internal review.
