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

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, … .

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endocrinology, UZ Ghent Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gastric bypass surgery

Procedure

Conservative weight loss program

Behavioral

Primary outcomes

Change from baseline in sex steroids

Time frame: 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

Time frame: 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

Time frame: baseline, 6 months, 1 year

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Acronym: SMELSS

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Nov 16, 2016
Registry last updated: Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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