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Behavioural Intervention

Metabolically normal obese Individuals (obesity with normoglycemia and normal liver fat content) for Non-alcoholic Fatty Liver Disease (ATM Trial)

N/A

Waitlist Available

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

ATM Trial 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.Check my eligibility

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.See study design

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.

ATM Trial 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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

24-hour plasma glucose concentration

Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure.

Macrophage isolation in adipose tissue biopsy

+1 more

ATM 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,364 Previous Clinical Trials

4,315,342 Total Patients Enrolled

46 Trials studying Non-alcoholic Fatty Liver Disease

9,970 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Bettina MittendorferLead Sponsor

1 Previous Clinical Trials

100 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,705 Previous Clinical Trials

7,507,226 Total Patients Enrolled

8 Trials studying Non-alcoholic Fatty Liver Disease

740 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 18 eligible for enrollment in this research study?

"Individuals aged above 18 years and below 70 years are eligible to participate in this research."

Answered by AI

Are new participants currently being recruited for this ongoing medical study?

"According to the details on clinicaltrials.gov, recruitment for this particular trial has concluded. The initial posting was made on March 1st, 2024, with the latest update occurring on March 21st of the same year. While this specific study is no longer accepting participants, there are currently 2748 alternative trials actively seeking candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity

Bettina Mittendorfer 2024. "Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06335771.

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