Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function

NCT ID: NCT01559779

Last Updated: 2014-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal glucose tolerance

Morbidly obese subjects with normal glucose tolerance undergoing gastric bypass surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Carsten Dirksen

MD PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carsten Dirksen, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Dpt. of Endocrinology (215) at Hvidovre Hospital

Hvidovre, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 24048673 (View on PubMed)

Other Identifiers

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AB-CD-10

Identifier Type: -

Identifier Source: org_study_id

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