SMELSS: Study on Mechanisms of Changes in Liver Disease and Sex Steroid Metabolism During Weight Loss
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 |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Gastric Bypass Surgery Solid mixed meal tolerance test, MRI, CT, anthropometrics, liver biopsies, fat biopsies, muscle biopsies |
Procedure: Gastric bypass surgery
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Conservative weight loss Solid mixed meal tolerance test, MRI, CT, anthropometrics, liver biopsies, fat biopsies, muscle biopsies |
Behavioral: Conservative weight loss program
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Outcome Measures
Primary Outcome Measures
- 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.
- 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
- Correlation in changes in liver fat en changes in sex steroids [baseline, 6 months, 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed consent obtained
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BMI > 35 kg/m²
Exclusion Criteria:
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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.
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Type 2 Diabetes Mellitus treated with insulin or GLP-1 analogues
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Current or recent use of insulin, corticosteroids, opiates (on a daily basis), growth hormones, androgen- or estrogen analogs, levothyroxine, anti-retroviral drugs or antipsychotics
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Cancer (within < 5 years)
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High-grade malignancies
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Serious co-morbidities such as renal, hepatic of cardiac failure
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Known or suspected abuse of alcohol or narcotics
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Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- B670201526667