Trial · Interventional
CompletedPhase 4Registry dataThe Effect of Liraglutide on Dietary Lipid Induced Insulin Resistance in Humans
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 97 participants (actual)
- Sponsor
- Phoenix VA Health Care System · Fed
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Mar 2013
- Primary completion
- 28 Apr 2021
- Completion
- 1 Nov 2023
- First posted
- 31 Mar 2015 (estimated)
- Last update posted
- 22 Jul 2024
- Conditions
- Insulin Resistance
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
The Effect of Liraglutide on Dietary Lipid Induced Insulin Resistance in Humans
NCT02403284Mar 2013 to 1 Nov 2023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
In this research study, investigators will test the effects of an approved medication for diabetes,Liraglutide, to reduce insulin resistance that develops from eating a diet high in saturated fats.
Interventions
- LiraglutideDrug
- Sugar PillDrug
Arms2
Experimental
Liraglutide
Liraglutide titration up to 1.8 mg/d over approximately 3 weeks
Placebo comparator
Sugar pill
matching placebo and titration
Primary outcomes1
Outcomes the sponsor listed as primary.
Whole Body Insulin Sensitivity (insulin suppression test)
Time frame · 3 weeks
Registry description
An insulin suppression test will be measured before and approximately 3 weeks after each treatment phase. Key time frames for assessing steady state plasma glucose will be between 150 and 180 minutes during the insulin suppression test
Secondary outcomes(9)
Postprandial lipid changes (area under the curve difference in triglyceride,total apolipoprotein B100, apolipoprotein B48, and apolipoprotein C3.
Time frame · 3 weeks
Registry description
The major endpoints will be the area under the curve difference in triglyceride and free fatty acids between treatment arms on test day 1 and 2 following a standard meal. Other postprandial lipids will include total apolipoprotein B100, apolipoprotein B48, and apolipoprotein C3.
Postprandial changes in glucose metabolism (total and incremental area under the curve differences in glucose, insulin and glucagon)
Time frame · 3 weeks
Registry description
total and incremental area under the curve differences in glucose, insulin and glucagon between treatment arms
Changes in adipose tissue insulin signaling pathway activation (compare insulin signaling pathway activity (e.g., Akt and insulin receptor phosphorylation)
Time frame · 3 weeks
Registry description
Adipose tissue biopsy samples will be used to compare insulin signaling pathway activity (e.g., Akt and insulin receptor phosphorylation) in placebo and liraglutide treatment phases.
subcutaneous adipose tissue lipid intermediates (e.g., ceramide, diacylglycerol, acylcarnitine concentrations)
Time frame · 3 weeks
Registry description
Adipose tissue biopsy samples will be used to compare lipid intermediates in placebo and liraglutide treatment phases.
skeletal muscle tissue lipid intermediates (e.g., ceramide, diacylglycerol, acylcarnitine concentrations)
Time frame · 3 weeks
Registry description
skeletal muscle tissue samples will be used to compare lipid intermediates in placebo and liraglutide treatment phases.
Adipose tissue inflammation measures (e.g., interleukin (IL)-6, and -8, adiponectin, TNF-alpha, nuclear factor-kappa b, gene and protein expression)
Time frame · 3 weeks
Registry description
Adipose tissue biopsy samples will be used to compare inflammation measures in placebo and liraglutide treatment phases.
Skeletal muscle inflammation measures (e.g., IL-6,8, TNF-alpha, nuclear factor-kappa b gene and protein expression)
Time frame · 3 weeks
Registry description
skeletal muscle tissue samples will be used to compare inflammation measures in placebo and liraglutide treatment phases
Adipose tissue arteriole function (vasodilation measurement)
Time frame · 3 weeks
Registry description
Adipose tissue biopsy samples will be used to isolate arterioles and measure ex vivo vascular function in placebo and liraglutide treatment phases.
Changes in skeletal muscle insulin signaling pathway
Time frame · 3 weeks
Registry description
skeletal muscle biopsy samples will be used to compare insulin signaling pathway activity (e.g., Akt and insulin receptor phosphorylation) in placebo and liraglutide treatment phases.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 40 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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