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The Endocrine Secretome After Gastric Bypass Surgery

CompletedNA

Sponsor: Filip Krag Knop

Conditions: Obesity, Morbid, Type2 Diabetes

Interventions: Enteroscopy with biopsy sampling and mixed meal test

Examination of the molecular phenotype and composition of endocrine cells in the gastrointestinal tract correlated to analyses of blood for hormones/analytes before and after Roux-en-Y gastric bypass surgery in morbidly obese individuals both with and without type 2 diabetes

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Obese subjects referred for assessment of eligibility for RYGB surgery
* Age ≥25 and ≤ 60 years
* Able to understand written patient information and obtained signed informed consent
* Type 2 diabetes patients treated with lifestyle, metformin and/or sulfonylurea will be allowed participation.

Exclusion Criteria:

* Diagnosis of diabetes mellitus type 1
* Individuals being categorized as subjects with type 2 diabetes according to ADA 2014 criteria AND currently being treated with DPPIV inhibitors, GLP-1 agonists, insulin and/or SGLT2 inhibitors.
* Co-morbidities that, in the discretion of the investigators, exclude study participation such as chronic obstructive pulmonary disease (COPD) stage III, significant cardiac arrhythmias etc.
* Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy).
* Gastrointestinal conditions making the subject unsuitable to participate in the study such as ulcerative colitis, Crohn´s disease, clinically significant food allergies, candidiasis etc.
* Chronic systemic inflammatory diseases (e.g,. rheumatoid arthritis) and other conditions significantly affecting inflammation status or immunoregulation (severe allergies, status post transplantation etc.)
* Chronic, planned or likely-to-be-required parenteral or oral corticosteroid medication during the study period, or (parenteral or oral) corticosteroid medication \<4 weeks prior to screening
* Chronic infectious diseases such as hepatitis, HIV etc.
* Anaemia with a haemoglobin value 6.2 mmol/L (\<10 g/dL) for women and 7.4 mmol/L (\< 12 g/dL) for men at time of screening
* Clinically significant liver or kidney function impairment, or other laboratory findings leading to the diagnosis of clinically relevant disorders (severe thyroid dysfunction etc)
* Planned elective surgery (other than bariatric surgery) during the study period with the exception of dermatosurgical, ENT (ear, nose, throat) or dental procedures not requiring general anaesthesia and/or perioperative antibiotic treatment
* Abuse of alcohol and/or drugs, or any other co-existing conditions that will make the subject unsuitable to participate in the study, as deemed by the investigators
* Pregnancy or desire to become pregnant during the study period