Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity (ATM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorBettina Mittendorfer
About this trial
The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals.
Both groups will have:
* screening visit * imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \[MRI\] and magnetic resonance spectroscopy \[MRS\] scans) * Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age: ≥18 but ≤70 years
not pregnant or breastfeeding
weight stable and sedentary before enrollment
no use tobacco products, excessive amounts of alcohol, or dietary supplements, or medications known to or suspected to affect glucose and lipid metabolism (aside from certain medications used to treat diabetes in the metabolically abnormal obesity [MAO]-Type 2 Diabetes group)
Disqualifiers
None
Trial population
All Volunteers , separated into 4 groups as per eligibility Criterion.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 4 trial groupsGroup A: Lean Individuals
Group B: Metabolically abnormal obese Individuals
Group C: Metabolically normal obese Individuals
Group D: Individuals with Type 2 Diabetes Mellitus
Trial outcomes
Primary outcomes
1
Insulin sensitivity
Sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure
Time frame
Within 2 weeks of Clinical Visit2
24-hour plasma glucose concentration
Time frame
Within 2 weeks of Clinical Visit3
Macrophage isolation in adipose tissue biopsy
macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)
Time frame
Within 2 weeks of Clinical Visit4
Macrophage isolation in skeletal muscle tissue
macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)
Time frame
Within 2 weeks of Clinical VisitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bettina Mittendorfer
Lead sponsor
University of Missouri-Columbia
Sponsor institution
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Washington University School of Medicine
Collaborator
Source ClinicalTrials.gov