Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
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 Participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss.
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 design
Design model
Parallel
Treatments tested in this trial
Dietary consultation weight loss intervention
Other interventionParticipants will meet with a member of the study team biweekly for about 6 months.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Lean IndividualsNo intervention 0 interventions
Group B: Metabolically abnormal obese Individuals (obesity with normoglycemia and abnormal liver fat content)Experimental treatment 1 intervention
Group C: Metabolically normal obese Individuals (obesity with normoglycemia and normal liver fat content)Experimental treatment 1 intervention
Group D: Individuals with Type 2 Diabetes MellitusExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure.
Time frame
up to 6 months after the intervention2
24-hour plasma glucose concentration
Time frame
up to 6 months after the intervention3
Macrophage isolation in adipose tissue biopsy
macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)
Time frame
up to 6 months after the intervention4
Macrophage isolation in skeletal muscle tissue
macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)
Time frame
up to 6 months after the interventionSponsors and contacts
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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