Evaluating the role of macrophages in obesity and metabolic function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate how the transcription factor EB (TFEB) influences lipid metabolism in adipose tissue macrophages among individuals with metabolically abnormal obesity compared to lean individuals. Participants will undergo a screening visit, body composition imaging, and an overnight visit that includes intravenous infusion and biopsies of muscle and fat tissue. The study focuses on understanding the metabolic differences between these groups to better comprehend obesity's impact on health.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.