Clinical trial NCT06441409: Effect of Lifestyle Intervention on Mobilization of Fat Storage and Iron Deposition in Obesity
Official title: Effect of Calorie-restricted Balanced Diet on Mobilization of Fat Storage Pools and Iron Deposition in Individuals With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Fat
Fertility Disorders
Life Style, Healthy
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients were intervened with lifestyle only.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The site-specific fat mobilization after 6 months' lifestyle intervention.
timeFrame: After 6 months intervention, patients were return to hospital for MRI analysis.
measure: 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.
Secondary outcomes:
measure: The correlation between liver fat and liver iron.
timeFrame: Patients were return to hospital for MRI and serum tests after lifestyle intervention for 6 months.
Other outcomes:
Locations:
city: Changsha
country: China
facility: the Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: Ping Jin
role: STUDY_CHAIR
References: