Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function

The Effect of Gastric Bypass Surgery on the Beta- and Alpha Cells Secretory Function and the Insulinotropic Effect of the Incretin Hormones

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01559779

Acronym

AB-CD-10

Enrollment

Registered

2012-03-21

Start date

2010-11-30

Completion date

2012-12-31

Last updated

2014-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Roux-en-Y gastric bypass, Incretin hormones, Beta cell function

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in beta cell function	Before and 1 week and 3 months after surgery	Change in first and second phase insulin response, disposition index, and acute insulin secretion in response to a non-glucose stimulus
Insulinotropic effect of incretin hormones	Before and 1 week and 3 months after surgery	Change in first and second phase insulin response during GLP-1 and GIP infusion compared to saline

Secondary

Measure	Time frame	Description
Change in alpha cell function	Before and 1 week and 3 months after surgery	Change in glucagon secretion in response to glucose and non-glucose stimuli

Countries

Denmark

Outcome results