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临床试验/NCT03875625
NCT03875625招募中不适用

Change of Adipose Tissues and Triglyceride in Obese Patients With Non-alcoholic Fatty Liver Disease After Bariatric Surgery or Life-style Intervention

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Use of modified Dixon Magnetic Resonance Imaging method to measure the response of adipose tissue in different organs following life style modification program or Bariatric surgery

研究概览

简要总结

The study is aimed

  • To quantify the change of adipose tissues, triglyceride in liver and pancreas and cholesterol after lifestyle intervention or bariatric surgery.
  • To test the hypothesis that Brown fat is an independent biomarker for the development of Non Alcoholic Fat Liver Disease (NAFLD)
  • To study the association among Brown fat, NAFLD and obesity.

详细描述

Obesity is associated with different chronic disorders such as metabolic syndrome, non-alcoholic fatty liver disease (NAFLD) and diabetes mellitus type 2 (DM2). It can be classified into mild, moderate and severe using different cut-off values of body mass index (BMI). Many interventions and treatments against obesity have been proposed. Patients with mild to moderate obesity are suggested to undergo lifestyle monitoring or intervention programs while patients with severe or morbid obesity may be suggested to undergo bariatric surgery. Brown adipose tissue (BAT) is a specific type of adipose tissue with unique ability to produce heat by non-shivering thermogenesis. It increases energy expenditure and lower blood glucose levels and therefore it is suggested to be a potential therapy against obesity, NAFLD, DM2 etc.

Research studies demonstrated that obesity is strongly associated with NAFLD. From our previous observation, most obese individuals suffer from NAFLD. Nevertheless, a small portion of them are protected from NAFLD. We try to understand why and how this small portion of severe obese patients can keep themselves protected from NAFLD while some lean individual suffers from it. We would also like to test whether the amount of BAT is a biomarker for NAFLD. Besides, we would like to validate the accuracy of liver inflammation and fibrosis (LIF) scores with liver biopsy results.

The change of adipose tissues (i.e. brown, subcutaneous, visceral), triglyceride in liver and pancreas and cholesterol (i.e. HDL and LDL) in bloodstream would be measured in patients with NAFLD who undergo either bariatric surgery or lifestyle intervention. 40 subjects will be recruited. Half of them for the lifestyle intervention group while half for the bariatric group. Baseline MRI and blood test will be performed before the start of their treatments and two follow-up scans as well as blood tests in six-month and twelve-month intervals.

This study allows objective measurement to evaluate efficacy of different treatments against obesity and the response of NAFLD after weight loss. Furthermore, this study provides quantitative measurement of BAT and tests whether BAT is associated with NAFLD or other metabolites disorders such as DM2 and hyperlipidemia.

b) Research plan and methodology Subjects Eighty volunteers will be recruited for this project. 40 of them with mild-moderate obesity and the other 40 subjects with morbid obesity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI ≥ 25-30 kg/m2
  • BMI ≥ 30 kg/m2 with Metabolic syndrome
  • BMI ≥ 35 kg/m2 for morbid obesity

排除标准

  • Other kind of hepatic diseases
  • Under medications known to affect liver fat
  • Waist circumference ≥ 150 cm
  • Weight ≥ 250 kg
  • MRI contraindications

结局指标

主要结局

Use of modified Dixon Magnetic Resonance Imaging method to measure the response of adipose tissue in different organs following life style modification program or Bariatric surgery

时间窗: one year

Abdominal subcutaneous fat in milliliters

Use of modified Dixon Magnetic Resonance Imaging method to measure the response of adipose tissue in different organs following life style modification program or Bariatric surgery 2

时间窗: one year

Abdominal Visceral fat in milliliters

Use of modified Dixon Magnetic Resonance Imaging method to measure the response of adipose tissue in different organs following life style modification program or Bariatric surgery- 4

时间窗: one year

pancreatic fat in percentage (%).

Blood biochemistry for assessing β-cell function and insulin resistance (IR)

时间窗: one year

Homeostatic model assessment (HOMA) (Fasting glucose in nanomoles per liter (nmol/L) and insulin in (micro-units Per Litre).

Blood biochemistry- 4

时间窗: one year

To measure ALT in International Units Per Litre (IU/L)

Use of modified Dixon Magnetic Resonance Imaging method to assess the relationship between Brown Adipose Tissue and Non Alcoholic Fatty Liver Disease

时间窗: one year

Brown fat in milliliters

Use of modified Dixon Magnetic Resonance Imaging method to measure the response of adipose tissue in different organs following life style modification program or Bariatric surgery- 3

时间窗: one year

Liver fat in percentage (%).

Blood biochemistry- 3

时间窗: one year

To measure Low-Density Lipoproteins in millimoles per litre (mmol/L)

Blood biochemistry- 2

时间窗: one year

To measure high density lipoproteins in millimoles per litre (mmol/L)

Blood biochemistry- 6

时间窗: one year

To measure gamma-glutamyltransferase (GGT) in International Units Per Litre (IU/L)

Blood biochemistry- 5

时间窗: one year

To measure AST in International Units Per Litre (IU/L)

Blood biochemistry- 1

时间窗: one year

To measure Triglycerides in millimoles per litre (mmol/L)

Anthropomorphic measurements using measuring tape and weight scale

时间窗: one year

BMI in kg/m\^2 (weight in kg and height in meters)

Anthropomorphic measurements using BP machine

时间窗: one year

Systolic and Diastolic Blood pressure in millimeters of mercury (mmHg)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Winnie W.C. Chu

Professor

Chinese University of Hong Kong

研究点 (1)

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