The Endocrine Secretome After Gastric Bypass Surgery

NCT03093298 | Completed

• 1 other identifier: H-6-2014-047
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obesity, Morbid; Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Altered gene expression in the endocrine secretome following Roux-en-Y gastric bypass surgery

  Each participant went through six study days (two mixed meal tests and one enteroscopy procedure before and after Roux-en-Y gastric bypass surgery, respectively)

Study Arms (1)

Obesity

EXPERIMENTAL

Enteroscopies with biopsy retrieval and mixed meal tests with blood sampling

Other: Enteroscopy with biopsy sampling and mixed meal test

Interventions

Enteroscopy with biopsy sampling and mixed meal test OTHER

Enteroscopies with biopsy retrieval and mixed meal tests with blood sampling before and after Roux-en-Y gastric bypass surgery

Obesity

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Filip Krag Knop: lead
• Sanofi: collaborator

Related Publications (3)

• Gilliam-Vigh H, Suppli MP, Heimburger SMN, Lund AB, Knop FK, Ellegaard AM. Cholesin mRNA Expression in Human Intestinal, Liver, and Adipose Tissues. Nutrients. 2025 Feb 8;17(4):619. doi: 10.3390/nu17040619.

  PMID: 40004948 DERIVED

• Jorsal T, Christensen MM, Mortensen B, Nygaard EB, Zhang C, Rigbolt K, Wandall E, Langholz E, Friis S, Worm D, Floyd A, Helgstrand F, Stoving RK, Aldries AR, Juhl CB, Ostergaard T, Rydborg T, Forman JL, Sorensen F, Schmidt T, Falkenhahn M, Musholt PB, Theis S, Larsen PJ, Rehfeld JF, Vrang N, Jelsing J, Vilsboll T, Knop FK. Gut Mucosal Gene Expression and Metabolic Changes After Roux-en-Y Gastric Bypass Surgery. Obesity (Silver Spring). 2020 Nov;28(11):2163-2174. doi: 10.1002/oby.22973.

  PMID: 33150746 DERIVED

• Jorsal T, Wewer Albrechtsen NJ, Christensen MM, Mortensen B, Wandall E, Langholz E, Friis S, Worm D, Orskov C, Stoving RK, Andries A, Juhl CB, Sorensen F, Forman JL, Falkenhahn M, Musholt PB, Theis S, Larsen PJ, Holst JJ, Vrang N, Jelsing J, Vilsboll T, Knop FK. Investigating Intestinal Glucagon After Roux-en-Y Gastric Bypass Surgery. J Clin Endocrinol Metab. 2019 Dec 1;104(12):6403-6416. doi: 10.1210/jc.2019-00062.

  PMID: 31276156 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip Knop, MD, prof.

  Gentofte Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, professor

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: March 28, 2017
• Study Start: December 12, 2014
• Primary Completion: December 13, 2016
• Study Completion: December 13, 2016
• Last Updated: March 28, 2017

Record last verified: 2017-03