Type 2 Diabetes
Conditions
Keywords
Obesity, Bariatric Surgery Candidate, Proteins, Biomarkers
Brief summary
This study focuses on identifying potentially predictive human circulating adipocyte and muscle biomarkers of diabetes remission after bariatric surgery in obese type 2 diabetic (T2D) subjects.
Detailed description
The study team at the Institute of Metabolic and Cardiovascular Diseases has recently identified several potential biomarkers (secreted by skeletal muscle and adipose tissue) of glucose homeostasis control using secretomic and metabolomic analyses. The goal of this study is to assess whether the addition of 9 adipocytes and myocytes plasma level could be associated with type 2 diabetes remission one year after bariatric surgery and would improve established clinical models of prediction of diabetes remission. Thus, obese type 2 diabetes patients undergoing bariatric surgery will have 2 blood samples, a muscle sample and one adipose tissue sample withdrawn during the study. From those samples, concentrations of 9 candidate proteins is measured : GDF6, INHBB, IL17B, TGFB2, TIMP1, VTN, MDK, GDF15, and apoM
Interventions
PROCEDUREblood samples
\- Research blood sample: 2 additional tubes compared to the classic sample for the analysis of the 9 research molecules.
PROCEDUREcollection of body tissues
removal of intra-abdominal fat and muscle tissue
PROCEDUREroutine care procedure
* Routine care blood sample: Full vitamin panel, CBC, liver panel, urea, creatinine, blood ionogram, blood calcium, phosphorus, magnesium at all visits, except the morning of surgery when only ß HCG (for women of childbearing age), HbA1c. * clinical examination : weight, height, waist measurement, cardiovascular examination, digestive system examination. * dosage of ß HCG for womens.
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is an exploratory pilot study, comparing for the first time in humans, the remission of type 2 diabetes, one year after bariatric surgery, with regard to circulating concentrations of 9 candidate proteins measured at T0.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Obese patients of at least grade 2 (body mass index ≥ 35 kg/m²) * Type 2 diabetics * About to undergo bariatric surgery at the Toulouse University Hospital * Affiliated or beneficiaries of a social security plan. * Having provided a free, informed and written consent, signed
Exclusion criteria
* Type 1 diabetic subjects or Maturity-Onset Diabetes of the Youth. * Pregnant and breastfeeding women. * Vulnerable persons as defined in the Public Health Code: protected adults (guardianship, curators), unable to express their consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between plasma levels of 9 target molecules and diabetes remission | Immediately before the Surgery (day 0) | The correlation between plasma levels of 9 target molecules (1 for each molecule) and diabetes remission will be evaluated through plasmatic dosages. The plasma determination of apolipoprotein M will be performed by mass spectrometry, and the 8 other molecules will be determined by the ELISA technique. The dosage is measured in mmol/l. Complete remission of T2DM will be defined according to the following criteria: HbA1c \< 5.7% and fasting blood glucose \< 5.6 mmol/l. Partial remission of T2DM will be defined as: HbA1c between 5.7 and 6.5% and fasting blood glucose between 5.6 and 6.9 mmol/l without any antidiabetic treatment. Finally, the absence of remission will include patients whose HbA1c is greater than or equal to 6.5% or fasting blood glucose greater than or equal to 7 mmol/l with one or more antidiabetic treatments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Areas under the ROC curves of different logistic regression models fitted to known clinical prediction scores (DiaRem, Ad-DiaRem). | At 3 months post-surgery | The DiaRem and Ad-DiaRem scores are weighted scoring systems based on initial pre-surgical factors that were specifically created to predict remission of type 2 diabetes after bariatric surgery. |
| the kinetics of the plasma levels of each of the 9 molecules studied | Immediately before the Surgery (day 0) | the kinetics of the plasma levels of each of the 9 molecules will be studied by measuring each factor on an empty stomach: the day of the operation in the digestive surgery department. |
| The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell | At the day of the inclusion | The expression level of the genes encoding 9 biomarkers in the adipocyte and the muscle cell will be evaluated by measuring the mRNA quantities of the genes of these 9 proteins |
Countries
France
Contacts
PRINCIPAL_INVESTIGATOREmilie MONTASTIER, MD
University Hospital, Toulouse
Outcome results
None listed