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

NCT06441409 | Completed

• 2 other identifiers: 22218No. 2022JJ40749
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Fat; Fertility Disorders; Life Style, Healthy; Glucose Metabolism Disorders (Including Diabetes Mellitus)

Outcome Measures

Primary Outcomes (2)

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

  Defined by percentage MRI-based fat loss. Calculated as (initial measurement minus follow-up measurement) / (initial measurement) × 100 and predefined to be assessed at 6-month follow-up. MRI scans were acquired with an INGENIA ELITION X (Philips Medical Systems Nederland B.V.).

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

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

  Defined by percentage MRI-based organ iron content loss. Calculated as (initial measurement minus follow-up measurement) / (initial measurement) × 100 and predefined to be assessed at 6-month follow-up. MRI scans were acquired with an INGENIA ELITION X (Philips Medical Systems Nederland B.V.).

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

Secondary Outcomes (1)

• The correlation between liver fat and liver iron.

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

Study Arms (1)

lifestyle intervention

EXPERIMENTAL

Patients were intervened with lifestyle only and returned to clinic for tests in 6 months. Lifestyle intervention included the diet and exercise. Diet was an energy-restricted balanced diet. Exercise requires 5 days a week and 30 minutes every day.

Behavioral: Lifestyle intervention

Interventions

Lifestyle intervention BEHAVIORAL

Patients were intervened with lifestyle only and returned to clinic for tests in 6 months. Lifestyle intervention included the diet and exercise. Diet was an energy-restricted balanced diet. Exercise requires 5 days a week and 30 minutes every day.

lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 ethanol intake exceeding 140 g/week for men and 70 g/week for women；

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

the Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Fatty Liver; Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ping Jin

  The Third Xiangya Hospital of Central South University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were intervened with lifestyle only.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: June 4, 2024
• Study Start: April 15, 2024
• Primary Completion: April 20, 2025
• Study Completion: April 28, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-05

Locations

CN (1)