Exploring how macrophages affect fat metabolism in obesity
Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity-Associated Diseases
This study tests how a specific protein in immune cells affects fat processing in people with obesity compared to those who are lean.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT06335771 on ClinicalTrials.gov |
What this trial studies
This study evaluates the role of transcription factor EB (TFEB) in adipose tissue macrophages and its impact on metabolic function in individuals with obesity compared to lean individuals. Participants will undergo screening, body composition imaging, and tissue biopsies, followed by a weight loss intervention for those with obesity. The study aims to understand differences in lipid metabolism between metabolically abnormal obesity and lean individuals.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 who are either lean or have metabolically normal obesity.
Not a fit: Patients with significant organ dysfunction, severe obesity, or those on medications affecting metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into obesity management and metabolic health.
How similar studies have performed: Other studies have explored macrophage roles in metabolism, but this specific approach focusing on TFEB in obesity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : * 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) * participants must fulfil all of the following group-specific inclusion criteria below: Lean group: * 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 % Metabolically normal obesity (MNO) group: * 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 % Metabolically abnormal obesity (MAO)-insulin resistance and non-alcoholic fatty liver disease (NAFLD) group: * 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 % MAO-type 2 diabetes group: * 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 Exclusion Criteria: \- Individuals that do not meet all inclusion Criterion
Where this trial is running
Columbia, Missouri
- University of Missouri School of Medicine — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Bettina Mittendorfer — University of Missouri-Columbia
- Study coordinator: Heather McHatton
- Email: heathermchatton@health.missouri.edu
- Phone: (573) 882-7619
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.