NCT06571474 Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity (ATM)
| NCT ID | NCT06571474 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bettina Mittendorfer |
| Condition | Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-08-01 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Bettina Mittendorfer
PRINCIPAL INVESTIGATOR
University of Missouri-Columbia
Frequently Asked Questions
Who can join the NCT06571474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06571474 currently recruiting?
Yes, NCT06571474 is actively recruiting participants. Contact the research team at heathermchatton@health.missouri.edu for enrollment information.
Where is the NCT06571474 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT06571474 clinical trial?
NCT06571474 is sponsored by Bettina Mittendorfer. The principal investigator is Bettina Mittendorfer at University of Missouri-Columbia. The trial plans to enroll 60 participants.
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