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

NCT ID: NCT02964780

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-19

Study Completion Date

2020-05-05

Brief Summary

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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, … .

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastric Bypass Surgery

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

Gastric bypass surgery

Intervention Type PROCEDURE

Conservative weight loss

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

Conservative weight loss program

Intervention Type BEHAVIORAL

Interventions

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Gastric bypass surgery

Intervention Type PROCEDURE

Conservative weight loss program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Endocrinology, UZ Ghent Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B670201526667

Identifier Type: -

Identifier Source: org_study_id