Weight Loss Effect on Circulating Liver Enzymes

Not Applicable

Completed

• Conditions: Liver Dysfunction; Visceral Fat
• Interventions: Behavioral: Weight loss group; Behavioral: Control group

• Registration Number: NCT02992639
• Lead Sponsor: Yonsei University

Brief 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 \[visceral fat area (VFA) at L4 ≥ 100 cm²\].

Detailed 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.

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-12-11
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-14
• Status Verified: 2017-01
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight loss group	Weight loss group	Mild calorie restriction group (300kcal/day intake reduction)
Control group	Control group	No calorie restriction group

Primary Outcome Measures

Name	Time	Method
Serum fatty acid levels (Relative peak area)	At 12-week follow-up
Change from baseline visceral fat area at L4 at 12-week (CT)	At baseline and 12-week follow-up
Visceral fat area at L4 (CT)	At 12-week follow-up

Secondary Outcome Measures

Name	Time	Method
Fat mass (DEXA)	At 12-week follow-up
Fat percentage (DEXA)	At 12-week follow-up
Change from baseline fat percentage at 12-week (DEXA)	At baseline and 12-week follow-up
Change from baseline fat mass at 12-week (DEXA)	At baseline and 12-week follow-up

Trial Locations

Locations (1)

Yonsei University; 🇰🇷 Seoul, Korea, Republic of