ObesityATMNCT06335771
Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity
A study testing Dietary consultation weight loss intervention in people with Obesity and Nonalcoholic Fatty Liver, run by Bettina Mittendorfer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Nonalcoholic Fatty Liver, Diabetes Type 2
- What is being tested?
- Dietary consultation weight loss intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 27Show fewer
- 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
Who cannot join
- Individuals that do not meet all inclusion Criterion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aman Pritish Aher contact
United States1 site, 1 recruiting
- Recruiting
University of Missouri School of Medicine
Columbia, Missouri, 65212
Bettina Mittendorfer, 573-882-9377, b.mittendorfer@missouri.edu
About this study
Official title: Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity-Associated Diseases
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.
- Conditions
- Obesity, Nonalcoholic Fatty Liver, Diabetes Type 2, Healthy
- Being tested
- Dietary consultation weight loss intervention
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary consultation weight loss interventionOther
Participants will meet with a member of the study team biweekly for about 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Lean Individuals | No intervention | No intervention will be administered. |
| Metabolically abnormal obese Individuals (obesity with normoglycemia and abnormal liver fat content) | Experimental | Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months. Receives: Other: Dietary consultation weight loss intervention |
| Metabolically normal obese Individuals (obesity with normoglycemia and normal liver fat content) | Experimental | Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months. Receives: Other: Dietary consultation weight loss intervention |
| Individuals with Type 2 Diabetes Mellitus | Experimental | Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months. Receives: Other: Dietary consultation weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure.
Measured: up to 6 months after the intervention
24-hour plasma glucose concentration
Measured: up to 6 months after the intervention
Macrophage isolation in adipose tissue biopsy
macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)
Measured: up to 6 months after the intervention
Macrophage isolation in skeletal muscle tissue
macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)
Measured: up to 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Aug 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bettina Mittendorfer
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Washington University School of Medicine
- Responsible party
- Sponsor-investigator, Bettina Mittendorfer, University of Missouri-Columbia
- Investigators
- Bettina Mittendorfer, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335771
- Sponsor's protocol ID
- 2098077
- Other IDs
- R01DK131188
- Acronym
- ATM
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity-Associated Diseases
- ClinicalTrials.gov ID
- NCT06335771
- Acronym / sponsor ID
- ATM / 2098077
- Conditions
- Obesity, Nonalcoholic Fatty Liver, Diabetes Type 2, Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bettina MittendorferUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Washington University School of Medicine
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lean Individuals | No intervention | –No intervention will be administered. |
| Metabolically abnormal obese Individuals (obesity with normoglycemia and abnormal liver fat content) | Experimental | Other: Dietary consultation weight loss interventionParticipants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months. |
| Metabolically normal obese Individuals (obesity with normoglycemia and normal liver fat content) | Experimental | Other: Dietary consultation weight loss interventionParticipants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months. |
| Individuals with Type 2 Diabetes Mellitus | Experimental | Other: Dietary consultation weight loss interventionParticipants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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)
Key exclusion criteria (1 listed)
- Individuals that do not meet all inclusion Criterion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary consultation weight loss interventionParticipants will meet with a member of the study team biweekly for about 6 months. | Other | Individuals with Type 2 Diabetes Mellitus, Metabolically abnormal obese Individuals (obesity with normoglycemia and abnormal liver fat content), Metabolically normal obese Individuals (obesity with normoglycemia and normal liver fat content) |
Primary outcome
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure.
Time frame: up to 6 months after the intervention
24-hour plasma glucose concentration
Time frame: up to 6 months after the intervention
Macrophage isolation in adipose tissue biopsy
Time frame: up to 6 months after the intervention
macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)
Macrophage isolation in skeletal muscle tissue
Time frame: up to 6 months after the intervention
macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aman Pritish Aher contact
Bettina Mittendorfer principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary consultation weight loss intervention in people with Obesity and Nonalcoholic Fatty Liver, run by Bettina Mittendorfer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather McHatton ((573) 882-7619, heathermchatton@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure. (time frame: up to 6 months after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.