Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity
Recruiting · Columbia, Missouri
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Study care at no cost to you
For your time and travel
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Most need no insurance or papers
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Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults age 18 through 70
- •Not pregnant or breastfeeding
- •Must have stable weight and be sedentary before joining
- •Not use tobacco products, excessive alcohol, or dietary supplements, and not take other glucose/lipid-affecting medications (except some diabetes medications for the MAO-type 2 diabetes group)
- •Must meet one of the study’s group rules for BMI, liver fat (IHTG), and blood sugar/HbA1c levels
🚫 You may not be able to join if…
- •Pregnant or breastfeeding
- •Uses tobacco products, excessive alcohol, or dietary supplements, or takes medications known to affect glucose and lipid metabolism (unless diabetes medications allowed for the MAO-type 2 diabetes group)
- •Has significant organ system dysfunction or disease (examples given include chronic severe kidney disease or cancer)
- •Does not meet all inclusion criteria
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults ages 18 to 70
- ✓Not pregnant or breastfeeding
- ✓Has obesity (and meets NAFLD/IHTG-related requirements per study group)
- ✓Must meet specific blood sugar and HbA1c ranges (varies by group)
- ✓No major organ dysfunction like severe kidney disease or cancer
- ✓No tobacco/excess alcohol/supplements or other glucose/lipid-affecting meds (with limited diabetes-med exceptions)
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- ✓Everyone in this study receives an active treatment — there is no placebo group.
- •There are 4 groups in this study.
What to expect, step by step
· This study lasts about 26 weeks (~6 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 26 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Other: Dietary consultation weight loss intervention
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
Who's running this study?
Sponsor
Bettina Mittendorfer
Overseen by Bettina Mittendorfer
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT06335771 · Locations: Missouri