- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02113215
Very Low Density Lipoprotein Turnover in Young and Elderly Individuals
May 10, 2016 updated by: The University of Texas Medical Branch, Galveston
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Galveston, Texas, United States, 77550
- University of Texas Medical Branch, Dept of Surgery
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy individuals from the Galveston area.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Young Males
Males, age 18-35 years.
9-hour Stable isotope infusion
|
9-hour infusion of stable isotope tracers
|
Young Females
Females, age 18-35 years.
9-hour Stable isotope infusion
|
9-hour infusion of stable isotope tracers
|
Older Males
Males, age 60-75.
9-hour Stable isotope infusion
|
9-hour infusion of stable isotope tracers
|
Older Females
Females, age 60-75.
9-hour Stable isotope infusion
|
9-hour infusion of stable isotope tracers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
9-hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Elisabet Borsheim, Ph.D., University of Texas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
April 10, 2014
First Submitted That Met QC Criteria
April 10, 2014
First Posted (Estimate)
April 14, 2014
Study Record Updates
Last Update Posted (Estimate)
May 12, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 11-318
- 1R01AG033761-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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