Plain English Summary
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)
Trial website
Contact information
Type
Scientific
Primary contact
Mr Steen Larsen
ORCID ID
http://orcid.org/0000-0002-5170-4337
Contact details
University of Copenhagen
Panum
Blegdamsvej 3b
Copenhagen
2200
Denmark
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
H-4-2009-095
Study information
Scientific title
Is mitochondrial function and lipid oxidation impaired in patients treated with simvastatin compared with well matched controls?
Acronym
Study hypothesis
Mitochondrial function and lipid oxidation is impaired with simvastatin treatment
Ethics approval
Ethical committee of Denmark, 09/09/2009, ref: H-4-2009-095
Study design
Observational cross-sectional study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Other
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
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
Phase
Drug names
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 trial start date
01/10/2009
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Mixed
Age group
Adult
Gender
Male
Target number of participants
20 subjects; 10 in the simvastatin treated group and 10 in the control group.
Total final enrolment
20
Participant exclusion criteria
1. Must not be taking medication (other than simvastatin).
2. Must not be disposed to type 2 diabetes
Recruitment start date
01/01/2010
Recruitment end date
31/05/2012
Locations
Countries of recruitment
Denmark
Trial participating centre
Xlab
University of Copenhagen
Panum
Blegdamsvej 3b
Copenhagen N
2200
Denmark
Sponsor information
Organisation
University of Copenhagen
Sponsor details
Xlab
Panum
Blegdamsvej 3b
Copenhagen
2200
Denmark
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
The Danish Council for Independent Research-Medical Sciences
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Nordea Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The data will be published in relevant international peer reviewed journals.
IPD sharing statement:
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.
Intention to publish date
31/12/2018
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30276217 (added 24/01/2020)