NCT02113215

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.6 years

First QC Date

April 10, 2014

Last Update Submit

May 10, 2016

Conditions

Keywords

aginglipid metabolismvery low density lipoproteins

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

Procedure: Stable Isotope Infusion

Young Females

Females, age 18-35 years. 9-hour Stable isotope infusion

Procedure: Stable Isotope Infusion

Older Males

Males, age 60-75. 9-hour Stable isotope infusion

Procedure: Stable Isotope Infusion

Older Females

Females, age 60-75. 9-hour Stable isotope infusion

Procedure: Stable Isotope Infusion

Interventions

9-hour infusion of stable isotope tracers

Older FemalesOlder MalesYoung FemalesYoung Males

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and muscle biopsies will be collected.

Study Officials

  • Elisabet Borsheim, Ph.D.

    University of Texas

    PRINCIPAL INVESTIGATOR

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

Locations