Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity (ATM)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2028-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Obesity Non-Alcoholic Fatty Liver Disease Diabetes Mellitus, Type 2 Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Lean Individuals

No intervention will be administered.

No interventions assigned to this group

Metabolically abnormal obese Individuals

Obesity with normoglycemia and abnormal liver fat content

No interventions assigned to this group

Metabolically normal obese Individuals

Obesity with normoglycemia and normal liver fat content

No interventions assigned to this group

Individuals with Type 2 Diabetes Mellitus

Pre-Diagnosed type 2 diabetics

No interventions assigned to this group

Eligibility Criteria

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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)

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