Change of Adipose Tissues and Triglyceride After Bariatric Surgery or Life-style Intervention

NCT03875625 | Recruiting DMC

• 1 other identifier: 2018.612
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Obesity, Morbid; Brown Fat; Metabolic Disease; Diabetes Mellitus; Insulin Resistance; Abdominal Subcutaneous Fat

Keywords

MRI; Dietitian Lifestyle intervention; Bariatric surgery; Brown adipose tissue; White adipose tissue; no alcoholic fatty liver disease; diabetes mellitus type 2; Pancreatic fat

Outcome Measures

Primary Outcomes (14)

• 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

  Abdominal subcutaneous fat in milliliters

  one year

• 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

  Abdominal Visceral fat in milliliters

  one year

• 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

  Liver fat in percentage (%).

  one year

• 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

  pancreatic fat in percentage (%).

  one year

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

  Brown fat in milliliters

  one year

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

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

  one year

• Blood biochemistry- 1

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

  one year

• Blood biochemistry- 2

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

  one year

• Blood biochemistry- 3

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

  one year

• Blood biochemistry- 4

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

  one year

• Blood biochemistry- 5

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

  one year

• Blood biochemistry- 6

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

  one year

• Anthropomorphic measurements using measuring tape and weight scale

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

  one year

• Anthropomorphic measurements using BP machine

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

  one year

Study Arms (4)

Morbid obesity- Bariatric surgery group

EXPERIMENTAL

Morbid obese subjects who will consent to bariatric surgery

Procedure: Bariatric surgery

Morbid obesity-Dietitian led life style intervention group

EXPERIMENTAL

Morbid obese subjects who will not consent to bariatric surgery but instead opt for dietitian led life style intervention

Behavioral: Dietitian led life style modification intervention

Mild obesity-Dietitian led life style intervention group

EXPERIMENTAL

Mild- Moderate subjects assigned through a randomized controlled trial to the dietitian led life style intervention

Behavioral: Dietitian led life style modification intervention

Mild obesity-Conventional care group (control)

EXPERIMENTAL

Mild- Moderate subjects assigned through a randomized controlled trial to conventional care

Behavioral: Conventional care (control)

Interventions

Bariatric surgery PROCEDURE

Use of the normal bariatric surgery procedures commonly conducted in our hospital, such as: Laparoscopic Roux-en-Y gastric bypass (RYGB) and Laparoscopic sleeve gastrectomy (LSG)

Morbid obesity- Bariatric surgery group

Dietitian led life style modification intervention BEHAVIORAL

Intensive 6 months life style changes supervised by diatitians.

Mild obesity-Dietitian led life style intervention group; Morbid obesity-Dietitian led life style intervention group

Conventional care (control) BEHAVIORAL

receive routine care

Mild obesity-Conventional care group (control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wale Hospital

Hong Kong, Shatin, Hong Kong

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity, Morbid; Metabolic Diseases; Diabetes Mellitus; Insulin Resistance; Diabetes Mellitus, Type 2

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Winnie C Chu, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Winnie C Chu, MD

CONTACT

(852) 3505 2299; winniechu@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Four groups of interventional groups will be applied. Group 1 for subjects with morbid obesity who have consented to bariatric surgery, Group 2 for subjects with morbid obesity and have opted for dietitian led lifestyle modification intervention, Group 3 and 4 for subjects with mild to moderate obesity randomly (RCT) assigned to either dietitian led life style modification intervention group or conventional care (control group).

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 15, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)