Study Stopped
PI left UTMB
Very Low Density Lipoprotein Turnover in Young and Elderly Individuals
2 other identifiers
observational
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 10, 2014
CompletedFirst Posted
Study publicly available on registry
April 14, 2014
CompletedMay 12, 2016
May 1, 2016
1.6 years
April 10, 2014
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
9-hours
Study Arms (4)
Young Males
Males, age 18-35 years. 9-hour Stable isotope infusion
Young Females
Females, age 18-35 years. 9-hour Stable isotope infusion
Older Males
Males, age 60-75. 9-hour Stable isotope infusion
Older Females
Females, age 60-75. 9-hour Stable isotope infusion
Interventions
9-hour infusion of stable isotope tracers
Eligibility Criteria
Healthy individuals from the Galveston area.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Medical Branch, Dept of Surgery
Galveston, Texas, 77550, United States
Biospecimen
Blood samples and muscle biopsies will be collected.
Study Officials
- PRINCIPAL INVESTIGATOR
Elisabet Borsheim, Ph.D.
University of Texas
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2014
First Posted
April 14, 2014
Study Start
December 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
May 12, 2016
Record last verified: 2016-05