CompletedNot Applicable

Effect of Lifestyle Intervention on Mobilization of Fat Storage and Iron Deposition in Obesity

China160 participantsStarted 2024-04-15

Plain-language summary

The goal of this clinical trial is to learn if calorie-restricted balanced diet could uniquely influence various fat storage pools and iron deposition and explore the relationships between fat or iron deposition loss in specific locations and glucose metabolism. The main questions it aims to answer are: After lifestyle intervention, which part of the body shows the fastest fat mobilization? Which part shows the slowest fat mobilization? Which area's fat mobilization is most related to the alleviation of glucose metabolism? Is there a relationship between the fat deposition in organs and the iron deposition in organs? Researchers will compare the liver fat, pancreatic fat, visceral fat, subscutaneous fat, liver and pancrease iron depositon after lifestyle intervention using self pre-and post-control . Participants will: Receive the lifestyle intervention in outpatient. Visit the clinic once after 6 months for checkups and tests. Keep a diary of their diet.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age between 18 and 70 years * have a BMI greater than 28.0 kg/m2 * exhibit abdominal obesity, defined as a waist circumference of at least 90 cm for men and 85 cm for women * willing to undergo a 6-month lifestyle intervention Exclusion Criteria: * For newly diagnosed patients with type 2 diabetes: those with fasting blood glucose ≥ 11.1 mmol/L, random blood glucose ≥ 16.7 mmol/L, or HbA1c ≥ 9.0%, or those exhibiting significant hyperglycemic symptoms, who need to start antidiabetic medication treatment immediately; * a prior history of pancreatic diseases; * combination of drug-induced hepatitis, autoimmune hepatitis, and viral hepatitis; * with a definitive diagnosis of diabetes who have already started medication treatment; * severe complications from type 2 diabetes or other significant diseases; * usage of drugs affecting body weight, insulin sensitivity, or metabolic-associated fatty liver disease in the past three months (such as insulin, glucocorticoids, thiazolidinediones, metformin, SGLT-2 inhibitors, or GLP-1 receptor agonists); * with malignant tumors; * acute or chronic infection; * with elevated transaminase levels of unknown cause; * hemochromatosis; * with iron deficiency anemia who are receiving iron supplementation; * who have donated blood or received a transfusion within the past six months; * who have experienced cardiovascular events within the past six months; * with acute or chronic blood loss; * alcohol dependence, defined as …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The site-specific fat mobilization after 6 months' lifestyle intervention.

Timeframe: After 6 months intervention, patients were return to hospital for MRI analysis.

The site-specific iron deposition mobilization after 6 months' lifestyle intervention.

Timeframe: Patients were return to hospital for MRI and serum tests after lifestyle intervention for 6 months.

Trial details

NCT IDNCT06441409

SponsorThe Third Xiangya Hospital of Central South University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-20

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