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

University Ghent

Status

Completed

Conditions

Obesity

Treatments

Procedure: Gastric bypass surgery

Behavioral: Conservative weight loss program

Study type

Observational

Funder types

Other

Identifiers

NCT02964780

B670201526667

Details and patient eligibility

About

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, ... .

Enrollment

90 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.