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

University Ghent90 enrolled

Overview

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, … .

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obesity

Interventions

Gastric bypass surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from baseline in sex steroids

The change in sex steroids will be compared between the conservative and the gastric bypass group.

Time frame: Baseline, 3 weeks, 6 weeks, 6 months, 1 year.

Change from baseline in liver fat

The change in liver steatose will be compared between the conservative and the gastric bypass group

Time frame: Baseline, 6 months, 1 year

Correlation in changes in liver fat en changes in sex steroids

Time frame: baseline, 6 months, 1 year