Study on Mechanisms of Changes in Liver Disease and Sex Steroid Metabolism During Weight Loss

Completed

• Conditions: Obesity
• Interventions: Procedure: Gastric bypass surgery; Behavioral: Conservative weight loss program

• Registration Number: NCT02964780
• Lead Sponsor: University Ghent

Brief Summary

The main objective of the study is to gain insight in the early dynamics and mechanisms of recovery of liver disease and sex steroid metabolism during weight loss in obese men and women and to investigate whether surgical weight loss has differential effects as compared to weight loss with life style measures. In addition, we want to evaluate the postprandial hypoglycemic reactive syndrome (PPHRS) in these patients using a standard chewable meal.

Secondary objectives are investigating determinants for the changes in sex steroids, liver disease and PPHRS. Possible determinants to be investigated are adipocytokine secretion patterns, body composition, resting metabolism rate, weight loss per se and changes in fat distribution, parameters of fatty acid metabolism, ... .

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-19
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-16
• Primary Completion: 2020-05-05
• Study Completion: 2020-05-05
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Informed consent obtained
• BMI > 35 kg/m²

Exclusion Criteria

• Primary or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
• Type 2 Diabetes Mellitus treated with insulin or GLP-1 analogues
• Current or recent use of insulin, corticosteroids, opiates (on a daily basis), growth hormones, androgen- or estrogen analogs, levothyroxine, anti-retroviral drugs or antipsychotics
• Cancer (within < 5 years)
• High-grade malignancies
• Serious co-morbidities such as renal, hepatic of cardiac failure
• Known or suspected abuse of alcohol or narcotics
• Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastric Bypass Surgery	Gastric bypass surgery	Solid mixed meal tolerance test, MRI, CT, anthropometrics, liver biopsies, fat biopsies, muscle biopsies
Conservative weight loss	Conservative weight loss program	Solid mixed meal tolerance test, MRI, CT, anthropometrics, liver biopsies, fat biopsies, muscle biopsies

Primary Outcome Measures

Name	Time	Method
Change from baseline in sex steroids	Baseline, 3 weeks, 6 weeks, 6 months, 1 year.	The change in sex steroids will be compared between the conservative and the gastric bypass group.
Change from baseline in liver fat	Baseline, 6 months, 1 year	The change in liver steatose will be compared between the conservative and the gastric bypass group
Correlation in changes in liver fat en changes in sex steroids	baseline, 6 months, 1 year

Trial Locations

Locations (1)

Endocrinology, UZ Ghent Hospital; 🇧🇪 Ghent, Belgium