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Trial · Interventional

CompletedPhase 4Registry data

The 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
201420162018202020222024
  1. Ph 4

    The Effect of Liraglutide on Dietary Lipid Induced Insulin Resistance in Humans

    NCT02403284

    Mar 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.

  1. 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)
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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
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

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