Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients
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ClinicalTrials.gov Identifier: NCT00844779 |
Recruitment Status
: Unknown
Verified April 2009 by University Hospital, Strasbourg, France.
Recruitment status was: Recruiting
First Posted
: February 16, 2009
Last Update Posted
: April 27, 2009
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Condition or disease | Intervention/treatment |
---|---|
Liver Disease | Procedure: Bariatric surgery Procedure: cholecystectomy or benign liver tumor removal |
Study Type : | Observational |
Estimated Enrollment : | 90 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Evaluation of Non Alcoholic Metabolic Liver Diseases in Patients Harboring Central Adiposity and Insulin Resistance by Biochemical and Functional Genomic Approaches |
Study Start Date : | February 2009 |
Estimated Primary Completion Date : | January 2011 |
Estimated Study Completion Date : | January 2011 |

Group/Cohort | Intervention/treatment |
---|---|
T
(n=30): without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor.
|
Procedure: cholecystectomy or benign liver tumor removal
cholecystectomy or benign liver tumor removal
|
A
(n=30): with central adiposity, insulin resistance and hepatic steatosis (histology).
|
Procedure: Bariatric surgery
Gastric bypass.
|
B
(n=30): with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology).
|
Procedure: Bariatric surgery
Gastric bypass.
|

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Group T(n=30): patient without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor
- Group A (n=30): patient with central adiposity, insulin resistance and hepatic steatosis (histology).
- Group B (n=30): patient with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology).
Exclusion Criteria:
- viral or autoimmune hepatitis
- hematochromatosis
- alcohol consumption (> 20 g/24h women, >30 g/24h men)
- type 1 diabetes
- inflammation or infection before procedure
- abnormal hemostasis or coagulation- pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844779
Contact: Ahmed Nassim DALI YOUCEF, PHD | (33) 3.69.55.11.84 | ahmed.nassim.dali.youcef@chru-strasbourg.fr | |
Contact: Michel DOFFOEL, MD | (33) 3 69 55 04 82 | michel.doffoel@chru-strasbourg.fr |
France | |
Service d'Hépato-Gastro-Entérologie - Nouvel Hôpital Civil | Not yet recruiting |
Strasbourg, France, 67091 | |
Contact: Michel DOFFOEL, MD (33) 3 69 55 04 82 michel.doffoel@chru-strasbourg.fr | |
Sub-Investigator: François HABERSETZER, MD | |
Principal Investigator: Michel DOFFOEL, MD | |
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil | Recruiting |
Strasbourg, France, 67091 | |
Contact: Michel VIX, MD (33) 3 69 55 10 52 michel.vix@chru-strasbourg.fr | |
Principal Investigator: Michel VIX, MD | |
Sub-Investigator: Jacques MARESCAUX, MD |
Principal Investigator: | Michel DOFFOEL, MD | Hôpitaux Universitaires de Strasbourg |
Responsible Party: | Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg |
ClinicalTrials.gov Identifier: | NCT00844779 History of Changes |
Other Study ID Numbers: |
3966 |
First Posted: | February 16, 2009 Key Record Dates |
Last Update Posted: | April 27, 2009 |
Last Verified: | April 2009 |
Keywords provided by University Hospital, Strasbourg, France:
Metabolic syndrome- hepatic steatosis- steatohepatitis - gene expression Non alcoholic fatty liver disease (NFALD) |
Additional relevant MeSH terms:
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases Insulin |
Liver Extracts Hypoglycemic Agents Physiological Effects of Drugs Hematinics |