Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity
NCT ID: NCT06335771
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2024-08-01
2028-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity (ATM)
NCT06571474
Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema
NCT03271034
"Can Soluble-CD163 Discriminate Between Healthy and Unhealthy Obese Individuals?"
NCT01463449
Metabolic Phenotyping for Personalized Obesity Therapy
NCT06874270
Postprandial Blood Cell Transcriptome of Normal Weight and Obese Subjects to 3 Caloric Doses of a High-fat Meal
NCT01995110
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.
Dietary consultation weight loss intervention
Participants will meet with a member of the study team biweekly for about 6 months.
Metabolically normal obese Individuals (obesity with normoglycemia and normal liver fat content)
Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.
Dietary consultation weight loss intervention
Participants will meet with a member of the study team biweekly for about 6 months.
Individuals with Type 2 Diabetes Mellitus
Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.
Dietary consultation weight loss intervention
Participants will meet with a member of the study team biweekly for about 6 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dietary consultation weight loss intervention
Participants will meet with a member of the study team biweekly for about 6 months.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Washington University School of Medicine
OTHER
Bettina Mittendorfer
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bettina Mittendorfer
Senior Associate Dean for Research; Professor, Medicine & Nutrition; NextGen Director of Clinical and Translational Sciences Unit
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bettina Mittendorfer
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Missouri School of Medicine
Columbia, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2098077
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.