ObesityABOSNCT01129297
A Biological Atlas of Severe Obesity (Biological Tissue Collection)
An observational study of Obesity and Glucose Intolerance, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Glucose Intolerance, Diabetes
- Type of treatment
- Pill or oral medicine
- How many people
- 20,000 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2006to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruiting: Clinical Medical Center from the north of France
Who may be able to join
- 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)
- 5)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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Francois PATTOU, MD PhD contact
Violeta Raverdy, MD contact
France1 site, 1 recruiting
- Recruiting
Lille University Hospital
Lille, Nord
François PATTOU, MD, PhD
About this study
Official title: Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection)
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.
Read the detailed description
Type 2 diabetes (T2D) is a disease commonly associated with obesity, which is an important risk factor for this condition. More than 80% of the diabetic subjects are obese. By analogy with the metabolic syndrome, the close association between obesity and T2D justifies the recognition of a new disease entity named by the neologism "diabesity".
This study will examine the contribution of different genetic variants on "diabesity" development, by integrating multiple genomics approaches (linkage analysis on whole genome, transcriptomics and bioinformatics) and analysis of biological pathways in relevant animals models and humans.
- Conditions
- Obesity, Glucose Intolerance, Diabetes
- Keywords
- Obesity, surgery, genetic expression, collection of samples
- Medical subject headings
- Obesity, Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (7)
Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)
Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin
Measured: 1 year
Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)
Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin
Measured: 2 years
Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)
Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin
Measured: 5 years
Prospective assessment of clinical and biological features before and after bariatric surgery
Prospective assessment of clinical and biological features before and after bariatric surgery: weight, BMI, blood pressure, alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), prothrombin time, platelets, serum triglyceride, cholesterolemia, fasting blood glucose, fasting insulin, blood glucose and insulin 120 minutes after ingestion of glucose (oral glucose tolerance test)
Measured: 1 year
Prospective assessment of clinical and biological features before and after bariatric surgery
Prospective assessment of clinical and biological features before and after bariatric surgery: weight, BMI, blood pressure, alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), prothrombin time, platelets, serum triglyceride, cholesterolemia, fasting blood glucose and fasting insulin, blood glucose and insulin 120 minutes after ingestion of glucose (oral glucose tolerance test)
Measured: 2 years
Prospective assessment of clinical ans biological features before and after bariatric surgery
Prospective assessment of clinical and biological features before and after bariatric surgery: weight, BMI, blood pressure, alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), prothrombin time, platelets, serum triglyceride, cholesterolemia, fasting blood glucose and fasting insulin, blood glucose and insulin 120 minutes after ingestion of glucose (oral glucose tolerance test)
Measured: 5 years
Genotype-Phenotype correlation
Genotype-Phenotype correlation based on medical and family history
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study start13 Jun 2006
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois PATTOU, MD PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129297
- Sponsor's protocol ID
- 2006_0620
- Other IDs
- DGS 2006/0307
- Acronym
- ABOS
- Status last verified
- Dec 2025
- First submitted
- 4 May 2010
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24531544Raverdy 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.
PubMed 37987186Saux 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.
PubMed 37652841Margerie 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.
PubMed 31159817
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection)
- ClinicalTrials.gov ID
- NCT01129297
- Acronym / sponsor ID
- ABOS / 2006_0620
- Conditions
- Obesity, Glucose Intolerance, Diabetes
- Keywords
- Obesity, surgery, genetic expression, collection of samples
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 13 Jun 2006 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 2 diabetes (T2D) is a disease commonly associated with obesity, which is an important risk factor for this condition. More than 80% of the diabetic subjects are obese. By analogy with the metabolic syndrome, the close association between obesity and T2D justifies the recognition of a new disease entity named by the neologism "diabesity".
This study will examine the contribution of different genetic variants on "diabesity" development, by integrating multiple genomics approaches (linkage analysis on whole genome, transcriptomics and bioinformatics) and analysis of biological pathways in relevant animals models and humans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruiting: Clinical Medical Center from the north of France
Key inclusion criteria (8 listed)
- 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 :
- 5)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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study the influence of phenotypic characteristics on gene expression of tissues involved in glucose metabolism
Time frame: Baseline
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
7 secondary outcomes
Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)
Time frame: 1 year
Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)
Time frame: 2 years
Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)
Time frame: 5 years
Prospective assessment of clinical and biological features before and after bariatric surgery
Time frame: 1 year
Prospective assessment of clinical and biological features before and after bariatric surgery
Time frame: 2 years
Prospective assessment of clinical ans biological features before and after bariatric surgery
Time frame: 5 years
Genotype-Phenotype correlation
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Results publication: PubMed 24531544Lien 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.
- Derived from this study: PubMed 37987186Raverdy 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.
- Derived from this study: PubMed 37652841Saux 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.
- Derived from this study: PubMed 31159817Margerie 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francois PATTOU, MD PhD contact
Violeta Raverdy, MD contact
Francois PATTOU, MD PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Glucose Intolerance, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francois PATTOU, MD PhD (fpattou@univ-lille2.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the influence of phenotypic characteristics on gene expression of tissues involved in glucose metabolism (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129297, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.