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Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity

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

Not stated in the study description — ask the study team about visits and procedures.

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 affects how the body uses energy. It is for adults who are lean or have obesity, with or without blood sugar problems. People with obesity will work with the study team to lose 10% of their body weight.

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 Participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss.

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

Eligibility

Who can join

  • Age 18–70, not pregnant or breastfeeding, with steady weight and little physical activity before joining.
  • No tobacco, heavy alcohol use, dietary supplements, or medicines that may affect blood sugar or fats. 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 meet all the rules for one of the four groups below. BMI is a weight-to-height measure. A1C measures average blood sugar over time.
  • Lean group: BMI 18.5 to under 25; liver fat under 5%; blood sugar before eating under 100 mg/dL; blood sugar 2 hours after a 75-gram sugar drink under 140 mg/dL; A1C under 5.7%.
  • Obesity with normal blood sugar group: BMI 30 to under 45; liver fat under 5%; blood sugar before eating under 100 mg/dL; blood sugar 2 hours after a 75-gram sugar drink under 140 mg/dL; A1C under 5.7%.
  • Obesity with trouble using insulin and fatty liver not caused by alcohol: BMI 30 to under 45; liver fat over 7.5%; blood sugar before eating 100 to under 126 mg/dL; blood sugar 2 hours after a 75-gram sugar drink 140 to under 200 mg/dL; A1C 5.7% to under 6.4%.
  • Obesity with type 2 diabetes: BMI 30 to under 45 and a type 2 diabetes diagnosis. If not diagnosed and treated, you must have one of these results without medicine: blood sugar before eating over 126 mg/dL, blood sugar 2 hours after a 75-gram sugar drink over 200 mg/dL, or A1C over 6.4%.

Who can't join

  • You cannot join if you do not meet all the required rules for taking part.

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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