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

NCT02964780 | Completed

• 1 other identifier: B670201526667
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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, … .

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• 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.

• 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

• Correlation in changes in liver fat en changes in sex steroids

  baseline, 6 months, 1 year

Study Arms (2)

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

Interventions

Gastric bypass surgery PROCEDURE

Gastric Bypass Surgery

Conservative weight loss program BEHAVIORAL

Conservative weight loss

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with obesity class 3 who want to reduce weight

You may qualify if:

• Informed consent obtained
• BMI \> 35 kg/m²

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Endocrinology, UZ Ghent Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: November 16, 2016
• Study Start: January 19, 2016
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: December 3, 2021

Record last verified: 2021-12

Locations

BE (1)