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

Sponsor
University Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT02964780
Collaborator
(none)
90
1
51.5
1.7

Study Details

Study Description

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, … .

Condition or Disease Intervention/Treatment Phase
  • Procedure: Gastric bypass surgery
  • Behavioral: Conservative weight loss program

Study Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Study on Mechanisms of Changes in Liver Disease and Sex Steroid Metabolism During Weight Loss
Actual Study Start Date :
Jan 19, 2016
Actual Primary Completion Date :
May 5, 2020
Actual Study Completion Date :
May 5, 2020

Arms and Interventions

Arm Intervention/Treatment
Gastric Bypass Surgery

Solid mixed meal tolerance test, MRI, CT, anthropometrics, liver biopsies, fat biopsies, muscle biopsies

Procedure: Gastric bypass surgery

Conservative weight loss

Solid mixed meal tolerance test, MRI, CT, anthropometrics, liver biopsies, fat biopsies, muscle biopsies

Behavioral: Conservative weight loss program

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  3. Correlation in changes in liver fat en changes in sex steroids [baseline, 6 months, 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Endocrinology, UZ Ghent Hospital Ghent Belgium 9000

Sponsors and Collaborators

  • University Ghent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Ghent
ClinicalTrials.gov Identifier:
NCT02964780
Other Study ID Numbers:
  • B670201526667
First Posted:
Nov 16, 2016
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2021