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

Obesity Clinical Trial

— SMELSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964780
• Other study ID #: B670201526667
• Status: Completed
• Start date: January 19, 2016
• Est. completion date: May 5, 2020

Study information

• Verified date: December 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, … .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 5, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Diseases
• Obesity
• Weight Loss

Intervention

Procedure:
• Gastric bypass surgery

Behavioral:
• Conservative weight loss program

Locations

Country	Name	City	State
Belgium	Endocrinology, UZ Ghent Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in sex steroids	The change in sex steroids will be compared between the conservative and the gastric bypass group.	Baseline, 3 weeks, 6 weeks, 6 months, 1 year.
Primary	Change from baseline in liver fat	The change in liver steatose will be compared between the conservative and the gastric bypass group	Baseline, 6 months, 1 year
Primary	Correlation in changes in liver fat en changes in sex steroids		baseline, 6 months, 1 year