Clinical trial NCT01559779: Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function
Official title: The Effect of Gastric Bypass Surgery on the Beta- and Alpha Cells Secretory Function and the Insulinotropic Effect of the Incretin Hormones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Roux-en-Y gastric bypass
Incretin hormones
Beta cell function
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2012-03-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital

Brief summary: The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric procedure that changes the gastrointestinal anatomy and has been demonstrated to cause remission of type 2 diabetes shortly after the operation, before any significant weight loss. The altered transit of nutrient through the gastrointestinal tract after the operation is thought to play a key role in this remission and studies have shown significant changes in the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1). However it is unknown whether the secretory function of the pancreatic islets as well as the stimulatory effect of the incretin hormones is changes postoperatively.


Eligibility criteria: Inclusion Criteria:

* Normal glucose tolerance
* Age \> 18 years
* BMI \> 40 or \> 35 if combined with hypertension or obstructive sleep apnoea
* Caucasian
* Normal hemoglobinaemia
* Signed informed consent

Exclusion Criteria:

* Major psychiatric disorder
* Alcohol or drug abuse
* Major hearth or pulmonary disease
* Previous major abdominal disease (e.g. peritonitis, large hernia)
* Pregnancy/lactation
* Treatment with GLP-1 analogs

Primary outcomes:
measure: Change in beta cell function
timeFrame: Before and 1 week and 3 months after surgery
measure: Insulinotropic effect of incretin hormones
timeFrame: Before and 1 week and 3 months after surgery
Secondary outcomes:
measure: Change in alpha cell function
timeFrame: Before and 1 week and 3 months after surgery
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dpt. of Endocrinology (215) at Hvidovre Hospital
state: Copenhagen
Study officials:
affiliation: Hvidovre University Hospital
name: Carsten Dirksen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dirksen C, Bojsen-Moller KN, Jorgensen NB, Jacobsen SH, Kristiansen VB, Naver LS, Hansen DL, Worm D, Holst JJ, Madsbad S. Exaggerated release and preserved insulinotropic action of glucagon-like peptide-1 underlie insulin hypersecretion in glucose-tolerant individuals after Roux-en-Y gastric bypass. Diabetologia. 2013 Dec;56(12):2679-87. doi: 10.1007/s00125-013-3055-1. Epub 2013 Sep 19.