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Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity (ATM)

Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity-Associated Diseases

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, X-rays, Biopsies, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how a protein called TFEB helps immune cells in body fat handle fat and affect blood sugar and fat use. It is for adults who are lean or have obesity, with or without blood sugar problems. Visits include body scans, an overnight stay, fluids given through a vein, and small samples of muscle and fat tissue.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 70, and not pregnant or breastfeeding.
  • Weight has stayed steady, with little physical activity before joining.
  • No tobacco, heavy alcohol use, supplements, or medicines that may affect blood sugar or fat use. Some diabetes medicines are allowed in the type 2 diabetes group.
  • No major organ problems or diseases, such as severe long-term kidney disease or cancer. You must also meet all rules for one group below.
  • Lean group: BMI (a weight-to-height measure) from 18.5 to below 25; liver fat below 5%; fasting blood sugar below 100 mg/dL; blood sugar below 140 mg/dL two hours after a sugar drink; and A1C (average blood sugar) below 5.7%.
  • Obesity with normal blood sugar group: BMI from 30 to below 45; liver fat below 5%; fasting blood sugar below 100 mg/dL; blood sugar below 140 mg/dL two hours after a sugar drink; and A1C below 5.7%.
  • Obesity with poor insulin response and fatty liver group: BMI from 30 to below 45; liver fat above 7.5%; fasting blood sugar from 100 to below 126 mg/dL; blood sugar from 140 to below 200 mg/dL two hours after a sugar drink; and A1C from 5.7% to below 6.4%.
  • Obesity with type 2 diabetes group: BMI from 30 to below 45, plus a type 2 diabetes diagnosis or a qualifying test without medicine if not already diagnosed and treated: fasting blood sugar above 126 mg/dL, blood sugar above 200 mg/dL two hours after a sugar drink, or A1C above 6.4%.

Who can't join

  • You cannot join if you do not meet all required rules for joining.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

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