A Biological Atlas of Severe Obesity (Biological Tissue Collection)

NCT01129297 | Recruiting

• 2 other identifiers: 2006_0620DGS 2006/0307
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes and obesity are both multifactorial diseases resulting from gene-environment interactions. However, this interaction, as well as the specific effect of each polymorphism, remains poorly understood. We now proposed a prospective cohort study to improve our understanding of the influence of phenotypic characteristics on gene expression in tissues involved in glucose and/or lipid metabolism by collecting different biological samples.

Conditions

Obesity; Glucose Intolerance; Diabetes

Keywords

Obesity; surgery; genetic expression; collection of samples

Outcome Measures

Primary Outcomes (1)

• Study the influence of phenotypic characteristics on gene expression of tissues involved in glucose metabolism

  Study the correlation between the glycemic status (fasting glucose and / or after ingestion of glucose) adjusted to the presence or absence of obesity (Body Mass Index) and gene expression in tissues involved in glucose metabolism before bariatric surgery

  Baseline

Secondary Outcomes (7)

• Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)

  1 year

• Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)

  2 years

• Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)

  5 years

• Prospective assessment of clinical and biological features before and after bariatric surgery

  1 year

• Prospective assessment of clinical and biological features before and after bariatric surgery

  2 years

Study Arms (5)

BMI ≥ 35 kg/m2 and diabetes

BMI (Body Mass Index) ≥ 35 kg/m2 and diabetes defined by a fasting blood glucose ≥ 7 mmol/l and/or ≥ to 11.1 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)

BMI ≥ 35 kg/m2 with intolerance glucose

BMI (Body Mass Index) ≥ 35 kg/m2 with intolerance glucose defined by a fasting blood glucose\> 6 mmol/L and \<7 mmol/l and / or\> 7.8 mmol/l and \<11.1 mmol/l , 120 minutes after ingestion of glucose (oral glucose tolerance test)

BMI ≥ 35 kg/m2 without diabetes

BMI (Body Mass Index)≥ 35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)

BMI <27 kg/m2 without diabetes

BMI (Body Mass Index) \<27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)

27 < BMI < 35 kg/m2 without diabetes

BMI (Body Mass Index) \<27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruiting: Clinical Medical Center from the north of France

You may qualify if:

• Age between 18 and 65 years
• Indication of abdominal surgery requiring a laparotomy or laparoscopy for bariatric surgery, cholecystectomy, or parietal surgical
• Phenotype corresponding to one of the following four cases :
• Body Mass Index ≥ 35 kg/m2 and diabetes defined by a fasting blood glucose ≥ 7 mmol/l and/or ≥ to 11.1 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
• Body Mass Index ≥ 35 kg/m2 with intolerance glucose defined by a fasting blood glucose\> 6 mmol/L and \<7 mmol/l and/or\> 7.8 mmol/l and \<11.1 mmol/l , 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
• Body Mass Index ≥ 35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
• Body Mass Index \<27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
• )27 \<Body Mass Index \<35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)

You may not qualify if:

• unable to receive clear information
• refusal to sign the consent form
• pathology associated judged by the surgeon, may increase the risk of adverse events related to sampling tissue

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Lille University Hospital

Lille, Nord, France

RECRUITING

Related Publications (4)

• Lien F, Berthier A, Bouchaert E, Gheeraert C, Alexandre J, Porez G, Prawitt J, Dehondt H, Ploton M, Colin S, Lucas A, Patrice A, Pattou F, Diemer H, Van Dorsselaer A, Rachez C, Kamilic J, Groen AK, Staels B, Lefebvre P. Metformin interferes with bile acid homeostasis through AMPK-FXR crosstalk. J Clin Invest. 2014 Mar;124(3):1037-51. doi: 10.1172/JCI68815. Epub 2014 Feb 17.

  PMID: 24531544 RESULT

• Raverdy V, Chatelain E, Lasailly G, Caiazzo R, Vandel J, Verkindt H, Marciniak C, Legendre B, Bauvin P, Oukhouya-Daoud N, Baud G, Chetboun M, Vantyghem MC, Gnemmi V, Leteurtre E, Staels B, Lefebvre P, Mathurin P, Marot G, Pattou F. Combining diabetes, sex, and menopause as meaningful clinical features associated with NASH and liver fibrosis in individuals with class II and III obesity: A retrospective cohort study. Obesity (Silver Spring). 2023 Dec;31(12):3066-3076. doi: 10.1002/oby.23904.

  PMID: 37987186 DERIVED

• Saux P, Bauvin P, Raverdy V, Teigny J, Verkindt H, Soumphonphakdy T, Debert M, Jacobs A, Jacobs D, Monpellier V, Lee PC, Lim CH, Andersson-Assarsson JC, Carlsson L, Svensson PA, Galtier F, Dezfoulian G, Moldovanu M, Andrieux S, Couster J, Lepage M, Lembo E, Verrastro O, Robert M, Salminen P, Mingrone G, Peterli R, Cohen RV, Zerrweck C, Nocca D, Le Roux CW, Caiazzo R, Preux P, Pattou F. Development and validation of an interpretable machine learning-based calculator for predicting 5-year weight trajectories after bariatric surgery: a multinational retrospective cohort SOPHIA study. Lancet Digit Health. 2023 Oct;5(10):e692-e702. doi: 10.1016/S2589-7500(23)00135-8. Epub 2023 Aug 29.

  PMID: 37652841 DERIVED

• Margerie D, Lefebvre P, Raverdy V, Schwahn U, Ruetten H, Larsen P, Duhamel A, Labreuche J, Thuillier D, Derudas B, Gheeraert C, Dehondt H, Dhalluin Q, Alexandre J, Caiazzo R, Nesslany P, Verkindt H, Pattou F, Staels B. Hepatic transcriptomic signatures of statin treatment are associated with impaired glucose homeostasis in severely obese patients. BMC Med Genomics. 2019 Jun 3;12(1):80. doi: 10.1186/s12920-019-0536-1.

  PMID: 31159817 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Liver samples before and at 1 and 5 years after bariatric surgery * Muscle samples before and at 1 year after bariatric surgery * Subcutaneous fat samples before and at 3 month and 1 year after bariatric surgery * Visceral fat samples in the great omentum before bariatric surgery * Intestinal samples during gastric by-pass surgery * Blood samples

MeSH Terms

Conditions

Obesity; Glucose Intolerance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Francois PATTOU, MD PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francois PATTOU, MD PhD

CONTACT

fpattou@univ-lille2.fr

Violeta Raverdy, MD

CONTACT

vraverdi@univ-lille2.fr

Study Design

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

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 24, 2010
• Study Start: June 13, 2006
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

FR (1)