Weight Loss Effect on Circulating Liver Enzymes

Liver Dysfunction Clinical Trial

Official title:

Weight Loss Effect on Circulating Levels of Liver Enzymes in Overweight Subjects With High Visceral Fat Area: 12-week Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992639
• Other study ID #: VFA_liver enzyme
• Status: Completed
• Phase: N/A
• First received: December 11, 2016
• Last updated: February 14, 2017
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate weight loss effect with mild calorie restriction on circulating levels of liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral fat area (VFA) at L4 ≥ 100 cm²].

Description:

A 12-week randomized, placebo-controlled study was conducted on 80 nondiabetic and overweight subjects with high VFA. The participants divided into two groups: 12-week mild calorie restriction (a 300 kcal/day intake reduction, n=40) or no treatment (control, n=40). The randomization was according to computer-generated block randomization (placebo:test = 1:1). Before and after intervention period, venous blood samples were obtained from the subjects, and biochemical parameters including circulating liver enzymes were measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Able to give informed consent

• 20-60 years old

• Males and females

• Overweight (25.0 kg/m²= BMI <30 kg/m²)

• Absence of pregnancy or breast-feeding

• Stable body weight (body weight change <1kg for 3 months before screening)

• High visceral fat (VFA) at L4 (VFA at L4 =100 cm²)

• Without hypertension, type 2 diabetes, cardiovascular disease, or thyroid disease

• No use medication affecting body weight, energy expenditure, or glucose control for the last 6 months

Exclusion Criteria:

• Prior history of Cushing syndrome or malignancy

• Prior history of liver disease including chronic viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, or drug-induced liver disease

• Excess alcohol intake (based on WHO standard)

• History of intentional reduction in weight in the preceding 6 months

Related Conditions & MeSH terms

• Liver Diseases
• Liver Dysfunction
• Visceral Fat
• Weight Loss

Intervention

Behavioral:
• Control group
The participants who included in control group did not receive any treatment.
• Weight loss group
The participants who included in weight loss group followed a 12-week weight loss program consisting of a 300 kcal/day reduction of thier usual caloric intakes

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visceral fat area at L4 (CT)		At baseline
Primary	Visceral fat area at L4 (CT)		At 12-week follow-up
Primary	Change from baseline visceral fat area at L4 at 12-week (CT)		At baseline and 12-week follow-up
Primary	Serum fatty acid levels (Relative peak area)		At baseline
Primary	Serum fatty acid levels (Relative peak area)		At 12-week follow-up
Secondary	Fat percentage (DEXA)		At baseline
Secondary	Fat percentage (DEXA)		At 12-week follow-up
Secondary	Change from baseline fat percentage at 12-week (DEXA)		At baseline and 12-week follow-up
Secondary	Fat mass (DEXA)		At baseline
Secondary	Fat mass (DEXA)		At 12-week follow-up
Secondary	Change from baseline fat mass at 12-week (DEXA)		At baseline and 12-week follow-up