Effect of Liraglutide (Victoza) on Inflammation in Human Adipose Tissue and Blood (NCT02650206) | Clinical Trial Compass
CompletedPhase 1
Effect of Liraglutide (Victoza) on Inflammation in Human Adipose Tissue and Blood
United States56 participantsStarted 2015-01
Plain-language summary
The objective of this study is to test the hypothesis that liraglutide (commonly known as Victoza) can promote an anti-inflammatory macrophage phenotype in human adipose tissue and blood, thereby reducing localized and systemic inflammation which are risk factors for cardiovascular disease and may contribute to hyperglycemia. This will be done after 4 weeks of treatment during which weight will remain stable, and again after 12 weeks, during which liraglutide-related weight loss occurs.
Who can participate
Age range
40 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI between 25 and 42 kg/m2
* Diet-controlled diabetics, or diabetics on Metformin that have permission from Primacy Care Physician to wash-out of the drug for 6 weeks prior to the study and for the duration of the study
* HbA1C between 6.0 - 7.9 (those on Metformin must have a HbA1c level below 7.5 prior to wash-out period)
* Fasting Blood Glucose \< 150 mg/dl
* Women must be post-menopausal or surgically sterile within age range
* Subjects must live in vicinity of Stanford University
Exclusion Criteria:
* Prior Bariatric surgery
* Personal or family history of medullary thyroid cancer
* MEN2 Syndrome
* Thyroid Nodules (not evaluated by PCP)
* Pancreatitis (acute or chronic)
* Gallstones
* Fasting plasma triglycerides \> 400 mg/dl
* Cardiovascular disease
* Major organ disease
* Unstable hypertension (BP \>160/100 mm Hg)
* Heavy alcohol use
* Self-reported weight change of \>2kg over past 6 weeks
* Medication known to affect blood glucose, insulin sensitivity, or inflammation
* NSAIDs (must cease use 4 weeks prior to study enrollment)
* Previous use of liraglutide, Januvia, Byetta, or Lira.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Macrophage polarization: % M2 macrophages in adipose tissue and peripheral blood according to positivity for cell surface markers (measured by flow cytometry).