NCT01559779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

March 19, 2012

Last Update Submit

June 9, 2014

Conditions

Obesity

Keywords

ObesityRoux-en-Y gastric bypassIncretin hormonesBeta cell function

Outcome Measures

Primary Outcomes (2)

  • Change in beta cell function

    Change in first and second phase insulin response, disposition index, and acute insulin secretion in response to a non-glucose stimulus

    Before and 1 week and 3 months after surgery

  • Insulinotropic effect of incretin hormones

    Change in first and second phase insulin response during GLP-1 and GIP infusion compared to saline

    Before and 1 week and 3 months after surgery

Secondary Outcomes (1)

  • Change in alpha cell function

    Before and 1 week and 3 months after surgery

Study Arms (1)

Normal glucose tolerance

Morbidly obese subjects with normal glucose tolerance undergoing gastric bypass surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt. of Endocrinology (215) at Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24048673DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum specimens are retained

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carsten Dirksen, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD student

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

November 1, 2010

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

DK(1)