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Studying Macrophage Lipid Metabolism in Obesity

This study is looking at how fat tissue cells called macrophages (a type of immune cell) handle fats in people with obesity and those who are lean. Researchers want to understand the role of a specific protein, transcription factor EB (TFEB), in these macrophages and how it affects metabolism. Participants with obesity will receive a dietary consultation for weight loss, aiming for a 10% body weight reduction over about 6 months. The study will measure insulin sensitivity (how well your body uses insulin), 24-hour blood sugar levels, and examine macrophages from fat tissue. We are looking for adults aged 18 to 70 who are not pregnant or breastfeeding, are weight stable, and don't use tobacco or excessive alcohol. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 60 participants. It compares individuals with obesity to lean individuals.
What's involved
You would have a screening visit, imaging (DEXA, MRI, MRS scans), and an overnight stay with an IV, muscle, and fat tissue biopsies. If you have obesity, you'll also have bi-weekly dietary consultations for about 6 months.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken up to 6 months after the intervention.

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NCT06335771

Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity

Recruiting
NAAges 18–70InterventionalBasic science
Bettina Mittendorfer
~60 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Dietary consultation weight loss intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure.
Measured over up to 6 months after the intervention
+3 more outcomes measured

Conditions

Obesity
Nonalcoholic Fatty Liver
Diabetes Type 2
Healthy

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HealthyNonalcoholic Fatty Liver DiseaseObesityType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Bettina Mittendorfer · PRINCIPAL_INVESTIGATOR · University of Missouri-Columbia

Who to contact

Heather McHatton
[email protected]
(573) 882-7619
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)
no evidence of significant organ system dysfunction or disease (e.g. chronic severe kidney disease, cancer)
Body mass index (BMI) ≥18.5 but \<25.0 kg/m2
Intrahepatic triglyceride (IHTG) content \<5%
fasting blood glucose concentration: \<100 mg/dl
blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl
Hemoglobin A1C (HbA1c) \<5.7 %
BMI ≥30.0 but \<45.0 kg/m2
IHTG content \<5%
fasting blood glucose concentration: \<100 mg/dl
blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl
HbA1c \<5.7 %
BMI ≥30.0 but \<45.0 kg/m2
IHTG content \>7.5%
fasting blood glucose concentration: ≥100 but \<126 mg/dl
blood glucose concentration 2 h after a 75 g oral glucose challenge: ≥140 but \<200 mg/dl
HbA1c: ≥5.7 but \<6.4 %
BMI ≥30.0 but \<45.0 kg/m2
clinical diagnosis of type 2 diabetes or fasting blood glucose concentration \>126 mg/dl or blood glucose concentration 2 h after a 75 g oral glucose challenge\>200 mg/dl or HbA1c \>6.4 % without medication if not diagnosed and medically treated for diabetes

What this trial measures

  • Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure.up to 6 months after the intervention
  • 24-hour plasma glucose concentrationup to 6 months after the intervention
  • Macrophage isolation in adipose tissue biopsyup to 6 months after the intervention

    macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)

  • Macrophage isolation in skeletal muscle tissueup to 6 months after the intervention

    macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)