AgingNCT02113215
Very Low Density Lipoprotein Turnover in Young and Elderly Individuals
An observational study of Aging, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Intrahepatic and intramyocellular lipid concentrations are elevated in elderly individuals relative to young people, despite no significant difference in fasting plasma TAG concentrations. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Stable Isotope Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2013
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals from the Galveston area.
Who may be able to join
- Age 18 to 35 years, or 60 to 75 years.
- Body mass index ≤ 27 kg•m2
- Ability to sign informed consent.
- Score of ≥26 for Mini-Mental State Exam
Who cannot join
- Diabetics (plasma glucose concentration >200 mg/dl at 2 hr after oral intake of 75 g glucose).
- Fasting plasma triacylglycerol concentration above 500 mg/dl
- Kidney disease.
- Liver disease.
- Bleeding disorders.
- Anaemia (Hb < 13 g/dl in males or < 12 g/dl in females).
Show all 11Show fewer
- Endocrine disease (with the exception of well-regulated hypothyroidism).
- Positive hepatitis or HIV screens.
- Alcohol (CAGE questionnaire; abnormal liver enzyme values) or drug abuse (amphetamines, cocaine, opioids, marijuana).
- Lipid altering agents.
- Score of <26 for Mini-Mental State Exam
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch, Dept of Surgery
Galveston, Texas, 77550
About this study
Intrahepatic and intramyocellular lipid concentrations are elevated in elderly individuals relative to young people, despite no significant difference in fasting plasma TAG concentrations. Our general hypothesis is that the increase in intrahepatic fat with age results from reduced VLDL turnover, and therefore elderly individuals in this study will display lower VLDL turnover rates than young individuals. The aims of this study are a) to compare VLDL turnover in young and elderly individuals, and b) to compare a bolus method and a constant infusion method of assessing VLDL turnover.
Read the detailed description
Several studies have shown an association between hypertriacylglycerolaemia and coronary artery disease. Additionally, ectopic fat distribution, in particular, deposition of excess lipid within the liver and skeletal muscle, has been shown to correlate negatively with insulin sensitivity, thus presenting a metabolic milieu in which risk of developing type 2 diabetes is elevated. Previous research from our group has shown that the triacylglycerol (TAG) concentration within the liver, and within skeletal muscle fibres IMCLs (intramyocellular lipids), is increased in elderly individuals compared with young people. The elevation of lipids in these particular tissues for the elderly group was observed despite no statistically significant difference in fasting plasma TAG concentration. As the plasma TAG concentration during the postabsorptive state is largely determined by the production and clearance rates of very low density lipoprotein triacylglycerol (VLDL-TAG), and increased liver fat content has been shown to drive production of large VLDL particles, it is important to gain an understanding of whether VLDL synthesis and breakdown differs between young and elderly individuals. Such new knowledge may offer an insight into why tissue lipids are elevated in the elderly. At present, no data exist in the literature describing VLDL turnover in elderly people. We hypothesise that very low density lipoprotein turnover will be reduced in elderly individuals compared with young people. The aims of this study are a) to determine whether fractional synthesis and breakdown rates of both the protein and lipid parts of the VLDL are different between young and elderly individuals, and b) to determine whether VLDL turnover values appear different when calculated using a constant infusion tracer method as compared with a bolus tracer method. Eight young men, eight young women, eight elderly men and eight elderly women will each participate in an 8-hour infusion study. Stable isotopes of glycerol, amino acids and fatty acids will be infused, and blood samples will be drawn in intervals during the study.
- Conditions
- Aging
- Being tested
- Stable Isotope Infusion
- Keywords
- aging, lipid metabolism, very low density lipoproteins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable Isotope InfusionProcedure or surgery
9-hour infusion of stable isotope tracers
| Study group | Role | What they receive |
|---|---|---|
| Young Males | Males, age 18-35 years. 9-hour Stable isotope infusion Receives: Procedure: Stable Isotope Infusion | |
| Young Females | Females, age 18-35 years. 9-hour Stable isotope infusion Receives: Procedure: Stable Isotope Infusion | |
| Older Males | Males, age 60-75. 9-hour Stable isotope infusion Receives: Procedure: Stable Isotope Infusion | |
| Older Females | Females, age 60-75. 9-hour Stable isotope infusion Receives: Procedure: Stable Isotope Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Very Low Density Lipoprotein (VLDL) Turnover
Turnover rates of VLDL-triglycerides and VLDL-ApoB (apolipoprotein B)-100, including synthesis and breakdown rates, measured during a 9-hour infusion trial.
Measured: 9-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startDec 2011
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: PI left UTMB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Elisabet Borsheim, Ph.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113215
- Sponsor's protocol ID
- 11-318
- Other IDs
- 1R01AG033761-01A1
- Status last verified
- May 2016
- First submitted
- 10 Apr 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Low Density Lipoprotein Turnover in Young and Elderly Individuals
- ClinicalTrials.gov ID
- NCT02113215
- Acronym / sponsor ID
- 11-318
- Conditions
- Aging
- Keywords
- aging, lipid metabolism, very low density lipoproteins
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left UTMB
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 Apr 2014 (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.
Intrahepatic and intramyocellular lipid concentrations are elevated in elderly individuals relative to young people, despite no significant difference in fasting plasma TAG concentrations. Our general hypothesis is that the increase in intrahepatic fat with age results from reduced VLDL turnover, and therefore elderly individuals in this study will display lower VLDL turnover rates than young individuals. The aims of this study are a) to compare VLDL turnover in young and elderly individuals, and b) to compare a bolus method and a constant infusion method of assessing VLDL turnover.
Detailed description
Several studies have shown an association between hypertriacylglycerolaemia and coronary artery disease. Additionally, ectopic fat distribution, in particular, deposition of excess lipid within the liver and skeletal muscle, has been shown to correlate negatively with insulin sensitivity, thus presenting a metabolic milieu in which risk of developing type 2 diabetes is elevated. Previous research from our group has shown that the triacylglycerol (TAG) concentration within the liver, and within skeletal muscle fibres IMCLs (intramyocellular lipids), is increased in elderly individuals compared with young people. The elevation of lipids in these particular tissues for the elderly group was observed despite no statistically significant difference in fasting plasma TAG concentration. As the plasma TAG concentration during the postabsorptive state is largely determined by the production and clearance rates of very low density lipoprotein triacylglycerol (VLDL-TAG), and increased liver fat content has been shown to drive production of large VLDL particles, it is important to gain an understanding of whether VLDL synthesis and breakdown differs between young and elderly individuals. Such new knowledge may offer an insight into why tissue lipids are elevated in the elderly. At present, no data exist in the literature describing VLDL turnover in elderly people. We hypothesise that very low density lipoprotein turnover will be reduced in elderly individuals compared with young people. The aims of this study are a) to determine whether fractional synthesis and breakdown rates of both the protein and lipid parts of the VLDL are different between young and elderly individuals, and b) to determine whether VLDL turnover values appear different when calculated using a constant infusion tracer method as compared with a bolus tracer method. Eight young men, eight young women, eight elderly men and eight elderly women will each participate in an 8-hour infusion study. Stable isotopes of glycerol, amino acids and fatty acids will be infused, and blood samples will be drawn in intervals during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young Males | – | Procedure: Stable Isotope InfusionMales, age 18-35 years. 9-hour Stable isotope infusion |
| Young Females | – | Procedure: Stable Isotope InfusionFemales, age 18-35 years. 9-hour Stable isotope infusion |
| Older Males | – | Procedure: Stable Isotope InfusionMales, age 60-75. 9-hour Stable isotope infusion |
| Older Females | – | Procedure: Stable Isotope InfusionFemales, age 60-75. 9-hour Stable isotope infusion |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals from the Galveston area.
Key inclusion criteria (4 listed)
- Age 18 to 35 years, or 60 to 75 years.
- Body mass index ≤ 27 kg•m2
- Ability to sign informed consent.
- Score of ≥26 for Mini-Mental State Exam
Key exclusion criteria (11 listed)
- Diabetics (plasma glucose concentration >200 mg/dl at 2 hr after oral intake of 75 g glucose).
- Fasting plasma triacylglycerol concentration above 500 mg/dl
- Kidney disease.
- Liver disease.
- Bleeding disorders.
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 |
|---|---|---|
| Stable Isotope Infusion9-hour infusion of stable isotope tracers | Procedure or surgery | Older Females, Older Males, Young Females, Young Males |
Primary outcome
Very Low Density Lipoprotein (VLDL) Turnover
Time frame: 9-hours
Turnover rates of VLDL-triglycerides and VLDL-ApoB (apolipoprotein B)-100, including synthesis and breakdown rates, measured during a 9-hour infusion trial.
Results and safety
The study was stopped early (reason given: PI left UTMB). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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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.
Elisabet Borsheim, Ph.D. principal investigator
University of Texas
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 Aging, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 12 May 2016. 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 United States. 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 was stopped early (reason given: PI left UTMB). Results are not available in the source record.
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?
Very Low Density Lipoprotein (VLDL) Turnover (time frame: 9-hours). 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 12 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.