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The Effect of Liraglutide on Dietary Lipid Induced Insulin Resistance in Humans
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
97
actual
Study population
Healthy volunteers
Key I/E criterion
•BMI 22-35
Primary endpoint
•HOMA-IR (insulin sensitivity)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age 40-75 years old
2. Body mass index (BMI) from 22 to 35 kg/m2
3. Normal glucose tolerance as determined by fasting blood glucose (< 100 mg/dl) and 75 gm glucose load (2 hr glucose <140 mg/dl)
4. Fasting triglyceride levels ≥ 75 mg/dl and <500 mg/dl
Exclusion criteria
1. Type 1 or 2 diabetes mellitus or a hemoglobin A1c value >6.5 mg/dl
2. Any diabetes medications in the past month, thiazolidinedione medications in the prior 3 months or prior regular use of insulin
3. Lactose intolerance or avoidance of dairy products
4. Creatinine > 2.0 mg/dl or other laboratory evidence of active disease, including hepatic enzyme elevation (AST or ALT) > 2.5 x normal and anemia (Hct < 35)
5. Known 'Nonalcoholic Fatty Liver Disease'
6. Malabsorption of fat or other nutrients, severe lactose intolerance or other significant gastrointestinal or pancreatic problems (including history of acute or chronic pancreatitis).
7. Recent history of nausea or vomiting
8. Acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
9. Prior cardiovascular event, stable or unstable angina or other major illness in the past 6 months
10. Current regular use of anti-inflammatory medications or antioxidants in excess of a standard daily multi-vitamin, including over- the-counter medications and high dose salicylates (> 1 gm/ day)
11. Subjects receiving a lipid lowering medication must be on a stable dose for at least 6 weeks prior to participation.
12. Personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia 2
13. Ethanol consumption more than 4 oz day
14. Pregnancy, or lack of appropriate contraceptive use in premenopausal women (extremely rare in our older predominately male population)
15. Poorly controlled hypertension, systolic blood pressure (SBP) > 150 or diastolic blood pressure (DBP) > 90 on 2 or more occasions during screening visits. Subjects receiving blood pressure medication will be on a stable dosing for at least 6 weeks prior to participation.
16. BMI <22 and >35 kg/m2
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
2 endpointsWhole Body Insulin Sensitivity (insulin suppression test)
Time frame:3 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Postprandial changes in glucose metabolism (total and incremental area under the curve differences in glucose, insulin and glucagon)
Time frame:3 weeks
change from baseline, improvement
componentsPostprandial glucose, C-peptide AUC
Cardiometabolic biomarkers
1 endpointPostprandial lipid changes (area under the curve difference in triglyceride,total apolipoprotein B100, apolipoprotein B48, and apolipoprotein C3.
Time frame:3 weeks
Triglycerides, change
change from baseline, improvement
Other (unclassified)
7 endpointsChanges in adipose tissue insulin signaling pathway activation (compare insulin signaling pathway activity (e.g., Akt and insulin receptor phosphorylation)
Time frame:3 weeks
change from baseline, descriptive
subcutaneous adipose tissue lipid intermediates (e.g., ceramide, diacylglycerol, acylcarnitine concentrations)
Time frame:3 weeks
concentration, descriptive
skeletal muscle tissue lipid intermediates (e.g., ceramide, diacylglycerol, acylcarnitine concentrations)
Time frame:3 weeks
concentration, descriptive
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
change from baseline, improvement
Skeletal muscle inflammation measures (e.g., IL-6,8, TNF-alpha, nuclear factor-kappa b gene and protein expression)
Time frame:3 weeks
change from baseline, improvement
Adipose tissue arteriole function (vasodilation measurement)
Time frame:3 weeks
descriptive
Changes in skeletal muscle insulin signaling pathway
Time frame:3 weeks
change from baseline, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.