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

NCT ID: NCT06441409

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-04-28

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.

Detailed Description

Fat mobilization status is assessed using magnetic resonance, while the relief of glucose metabolism is determined based on the results of the OGTT before and after life style intervention.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lifestyle intervention

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.

Group Type: EXPERIMENTAL

Lifestyle intervention

Intervention Type: 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.

Interventions

Lifestyle intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping Jin

Role: STUDY_CHAIR

The Third Xiangya Hospital of Central South University

Locations

the Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

No. 2022JJ40749

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22218

Identifier Type: -

Identifier Source: org_study_id