Lipid MetabolismNCT01921075
Physiologic Plasticity of Intramyocardial Lipid Storage
An observational study of Lipid Metabolism, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The main goal of the present study was to provide a technical basis for future studies assessing the role of cardiac lipids. More specifically, non-invasive MR-Spectroscopy (MRS) techniques will be used in this study to: 1. assess the methodological reproducibility of MRS-measurements of cardiac lipids in humans 2. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism
- What is being tested?
- normal dietary behavior and Magnetic resonance spectroscopy
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: males between the age of 18 and 30 years with either a BMI of 18-24
Who may be able to join
- male
- age 18-30
- BMI <25
- healthy
- written informed consent
Who cannot join
- contraindications to MRI examinations (claustrophobia, implanted devices (pacemaker, insulin pump, neurostimulators))
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institute of Diagnostic Interventional and Pediatric Radiology, University Hospital Bern
Bern, CH-3010
About this study
Official title: Patterns and Plasticity of Orthotopic and Ectopic Fat Deposition and Associations With Insulin Sensitivity: A Magnetic-resonance-imaging and -Spectroscopy Study in Lean and Obese Individuals: Methodological Part
The main goal of the present study was to provide a technical basis for future studies assessing the role of cardiac lipids. More specifically, non-invasive MR-Spectroscopy (MRS) techniques will be used in this study to:
- assess the methodological reproducibility of MRS-measurements of cardiac lipids in humans
- investigate physiological variations of cardiac lipids by measuring day-to-day changes under identical conditions
- determining diurnal variations of cardiac lipids in humans
Read the detailed description
Background
Obesity is a well known risk factor for the development of glucose intolerance, type 2 diabetes mellitus and, consequently, diabetic complications like cardiovascular disease. Importantly, obesity is not only associated with lipid accumulation in adipose tissue (orthotopic fat deposition), but also in non-adipose tissues (ectopic fat deposition). Clinical studies have repetitively shown that muscular and hepatic lipid accumulation as well as elevated visceral adipose tissue is associated with the development of central and peripheral insulin resistance. In addition, recent data from animal studies show increasing evidence that two other organs, the heart and the pancreas, may also be involved in the pathophysiological processes of reduced insulin sensitivity. While reduced insulin secretion in the course of type 2 diabetes has been well documented, the importance of pancreatic fat deposition as an early step in this process has only recently been suggested based on animal models. Conversely, ischemic heart disease is one of the most dangerous complications of diabetes mellitus, its prevention thereby being a cornerstone of current diabetes management. Recent data suggest that changes in the lipid metabolism of the heart and associated epi- and myocardial lipid deposition may be earliest signs of diabetic cardiopathy.
Magnetic-Resonance-Imaging (MRI) and -Spectroscopy (MRS) are among the most versatile methods for non-invasive studies of human tissue and/or metabolism in vivo and in situ. The excellent soft tissue contrast of MRI has already led to the implementation of this method for the assessment of whole body lipid accumulation, whereas MRS has successfully been applied to study lipid metabolism of skeletal muscle and liver. The extended application of this method towards heart and pancreas will allow a comprehensive investigation of orthotopic and ectopic fat deposition in humans and its association with the development of insulin resistance and diabetes mellitus.
The methodological part of the study will focus on the physiologic plasticity of cardiac lipids in order to assess:
- methodological reproducibility ii) intra-individual physiological reproducibility by measuring day-to-day variations as well as variations during the day.
Objective
- Adapting and optimizing the single-voxel MRS sequence that is currently used for muscle and liver, such that respiratory and cardiac double-triggering enables spectroscopy of the cardiac muscle. ii) Validate the methodology under different standardized physiologic conditions.
Methods
Cardiac lipids are determined during five independent MR-examinations distributed over two days separated by one or two weeks. Both days included a measurement in the morning after an overnight fast (>8h) and one in the afternoon (8h after breakfast, 3.5h after lunch). To determine methodological reproducibility, the afternoon measurement was repeated on one of the two days (1h break). Preparation of the volunteers included perpetuation of their normal diet, but restricted physical activity for two preceding days. Cardiac lipids were determined by single-voxel MR-Spectroscopy.
- Conditions
- Lipid Metabolism
- Being tested
- normal dietary behavior, Magnetic resonance spectroscopy
- Keywords
- physiology, normal function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal dietary behaviorOther
normal dietary behavior during examination days
Magnetic resonance spectroscopyOther
Non-invasive diagnostic procedure
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | young (age<30), healthy, lean (BMI<25) volunteers Receives: Other: normal dietary behavior; Other: Magnetic resonance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intramyocardial lipid content
Measured: at baseline (morning of examination day 1)
Secondary outcomes (6)
Intramyocardial lipid content
Measured: evening of examination day 1, i.e. 8 hours after baseline
Intramyocardial lipid content
Measured: morning of examination day 2, i.e. 7 days after baseline
Intramyocardial lipid content
Measured: evening of examination day 2, i.e. 7 days & 8 hours after baseline
Intra-individual variation of intramyocardial lipid content
Difference between evening and morning measurement within examination day one
Measured: evening of examination day one, i.e. 8 hours after baseline
Intra-individual variation of intramyocardial lipid content
Difference between evening and morning measurement within examination day two
Measured: evening of examination day two, i.e. 7 days & 8 hours after baseline
Intra-individual difference of intramyocardial lipid content (morning) over one week
Difference between morning measurements of examination day 1 and examination day 2
Measured: morning of examination day one, i.e. 7 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid MetabolismStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Ith, PhD & MD/PhD, Principal investigator, University Institute of Diagnostic Interventional and Pediatric Radiology of the Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921075
- Sponsor's protocol ID
- 124/08
- Other IDs
- 1587
- Status last verified
- Aug 2013
- First submitted
- 5 Aug 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns and Plasticity of Orthotopic and Ectopic Fat Deposition and Associations With Insulin Sensitivity: A Magnetic-resonance-imaging and -Spectroscopy Study in Lean and Obese Individuals: Methodological Part
- ClinicalTrials.gov ID
- NCT01921075
- Acronym / sponsor ID
- 124/08
- Conditions
- Lipid Metabolism
- Keywords
- physiology, normal function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of the present study was to provide a technical basis for future studies assessing the role of cardiac lipids. More specifically, non-invasive MR-Spectroscopy (MRS) techniques will be used in this study to:
- assess the methodological reproducibility of MRS-measurements of cardiac lipids in humans
- investigate physiological variations of cardiac lipids by measuring day-to-day changes under identical conditions
- determining diurnal variations of cardiac lipids in humans
Detailed description
Background
Obesity is a well known risk factor for the development of glucose intolerance, type 2 diabetes mellitus and, consequently, diabetic complications like cardiovascular disease. Importantly, obesity is not only associated with lipid accumulation in adipose tissue (orthotopic fat deposition), but also in non-adipose tissues (ectopic fat deposition). Clinical studies have repetitively shown that muscular and hepatic lipid accumulation as well as elevated visceral adipose tissue is associated with the development of central and peripheral insulin resistance. In addition, recent data from animal studies show increasing evidence that two other organs, the heart and the pancreas, may also be involved in the pathophysiological processes of reduced insulin sensitivity. While reduced insulin secretion in the course of type 2 diabetes has been well documented, the importance of pancreatic fat deposition as an early step in this process has only recently been suggested based on animal models. Conversely, ischemic heart disease is one of the most dangerous complications of diabetes mellitus, its prevention thereby being a cornerstone of current diabetes management. Recent data suggest that changes in the lipid metabolism of the heart and associated epi- and myocardial lipid deposition may be earliest signs of diabetic cardiopathy.
Magnetic-Resonance-Imaging (MRI) and -Spectroscopy (MRS) are among the most versatile methods for non-invasive studies of human tissue and/or metabolism in vivo and in situ. The excellent soft tissue contrast of MRI has already led to the implementation of this method for the assessment of whole body lipid accumulation, whereas MRS has successfully been applied to study lipid metabolism of skeletal muscle and liver. The extended application of this method towards heart and pancreas will allow a comprehensive investigation of orthotopic and ectopic fat deposition in humans and its association with the development of insulin resistance and diabetes mellitus.
The methodological part of the study will focus on the physiologic plasticity of cardiac lipids in order to assess:
- methodological reproducibility ii) intra-individual physiological reproducibility by measuring day-to-day variations as well as variations during the day.
Objective
- Adapting and optimizing the single-voxel MRS sequence that is currently used for muscle and liver, such that respiratory and cardiac double-triggering enables spectroscopy of the cardiac muscle. ii) Validate the methodology under different standardized physiologic conditions.
Methods
Cardiac lipids are determined during five independent MR-examinations distributed over two days separated by one or two weeks. Both days included a measurement in the morning after an overnight fast (>8h) and one in the afternoon (8h after breakfast, 3.5h after lunch). To determine methodological reproducibility, the afternoon measurement was repeated on one of the two days (1h break). Preparation of the volunteers included perpetuation of their normal diet, but restricted physical activity for two preceding days. Cardiac lipids were determined by single-voxel MR-Spectroscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | Other: normal dietary behavior, Other: Magnetic resonance spectroscopyyoung (age<30), healthy, lean (BMI<25) volunteers |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- males between the age of 18 and 30 years with either a BMI of 18-24
Key inclusion criteria (5 listed)
- male
- age 18-30
- BMI <25
- healthy
- written informed consent
Key exclusion criteria (1 listed)
- contraindications to MRI examinations (claustrophobia, implanted devices (pacemaker, insulin pump, neurostimulators))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal dietary behaviornormal dietary behavior during examination days | Other | Volunteers |
| Magnetic resonance spectroscopyNon-invasive diagnostic procedure | Other | Volunteers |
Primary outcome
Intramyocardial lipid content
Time frame: at baseline (morning of examination day 1)
6 secondary outcomes
Intramyocardial lipid content
Time frame: evening of examination day 1, i.e. 8 hours after baseline
Intramyocardial lipid content
Time frame: morning of examination day 2, i.e. 7 days after baseline
Intramyocardial lipid content
Time frame: evening of examination day 2, i.e. 7 days & 8 hours after baseline
Intra-individual variation of intramyocardial lipid content
Time frame: evening of examination day one, i.e. 8 hours after baseline
Intra-individual variation of intramyocardial lipid content
Time frame: evening of examination day two, i.e. 7 days & 8 hours after baseline
Intra-individual difference of intramyocardial lipid content (morning) over one week
Time frame: morning of examination day one, i.e. 7 days after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ith, PhD & MD/PhD principal investigator
University Institute of Diagnostic Interventional and Pediatric Radiology of the Inselspital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipid Metabolism, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intramyocardial lipid content (time frame: at baseline (morning of examination day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2013.