Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/02/2018
Date assigned
21/03/2018
Last edited
21/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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.

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

Xlab

Sponsor details

University of Copenhagen
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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes