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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months after the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after the intervention
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,463 Previous Clinical Trials
4,337,343 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,058 Total Patients Enrolled
Bettina MittendorferLead Sponsor
2 Previous Clinical Trials
160 Total Patients Enrolled
Washington University School of MedicineOTHER
2,000 Previous Clinical Trials
2,344,198 Total Patients Enrolled