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Behavioural Intervention

Dietary Consultation for Obesity (ATM Trial)

N/A
Recruiting
Research Sponsored by Bettina Mittendorfer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after the intervention
Awards & highlights

Summary

This trial aims to understand how a specific protein, transcription factor EB (TFEB), in fat tissue immune cells may affect metabolism in obese individuals. The researchers will compare how these cells process fats in obese

Who is the study for?
This trial is for people with obesity-related conditions like fatty liver disease, type 2 diabetes, or those who are generally healthy. Participants should be willing to undergo body scans and biopsies. Those looking to lose weight may receive dietary consultations.
What is being tested?
The study aims to understand how fat tissue macrophages affect overall metabolic function in obese individuals compared to lean ones. It involves body composition testing, imaging scans, overnight IVs, and tissue biopsies.
What are the potential side effects?
Potential side effects are not detailed but may include discomfort from the DEXA/MRI/MRS scans, bruising or pain at biopsy sites, and typical risks associated with intravenous infusions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Macrophage isolation in adipose tissue biopsy
Macrophage isolation in skeletal muscle tissue

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Metabolically normal obese Individuals (obesity with normoglycemia and normal liver fat content)Experimental Treatment1 Intervention
Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.
Group II: Metabolically abnormal obese Individuals (obesity with normoglycemia and abnormal liver fat content)Experimental Treatment1 Intervention
Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.
Group III: Individuals with Type 2 Diabetes MellitusExperimental Treatment1 Intervention
Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.
Group IV: Lean IndividualsActive Control1 Intervention
No intervention will be administered.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,831 Total Patients Enrolled
48 Trials studying Non-alcoholic Fatty Liver Disease
9,440 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,451 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
800 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Bettina MittendorferLead Sponsor
2 Previous Clinical Trials
160 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
60 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~40 spots leftby Mar 2028
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