NCT01559792

Brief Summary

The investigators want to study the changes in secretion of gastrointestinal hormones, absorption and metabolism of food and liquids before and after gastric bypass and in patients who are gastric banded but are getting conversion to a gastric bypass. All patients are with normal glucose tolerance. The investigators hypothesis that food uptake/absorption of food is faster after gastric bypass and the secretion of gastrointestinal hormones change.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 months 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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

March 19, 2012

Last Update Submit

March 20, 2012

Conditions

Gastric BypassGastric Banding

Eligibility Criteria

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

all with normal glucose tolerance - patients who are undergoing gastric bypass and patients with a gastric band to are converted to gastric bypass

You may qualify if:

  • Normal glucose tolerance
  • Patients who are undergoing gastric bypass and patients with a gastric band to are converted to gastric bypass

You may not qualify if:

  • Diabetes,
  • Study population must undergo gastric bypass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hvidovre Hospital

Hvidovre, 2650, Denmark

RECRUITING

Hvidovre hospital

Hvidovre, 2650, Denmark

RECRUITING

Related Publications (2)

  • Bojsen-Moller KN, Jacobsen SH, Dirksen C, Jorgensen NB, Reitelseder S, Jensen JE, Kristiansen VB, Holst JJ, van Hall G, Madsbad S. Accelerated protein digestion and amino acid absorption after Roux-en-Y gastric bypass. Am J Clin Nutr. 2015 Sep;102(3):600-7. doi: 10.3945/ajcn.115.109298. Epub 2015 Aug 5.

    PMID: 26245808DERIVED

  • Jacobsen SH, Bojsen-Moller KN, Dirksen C, Jorgensen NB, Clausen TR, Wulff BS, Kristiansen VB, Worm D, Hansen DL, Holst JJ, van Hall G, Madsbad S. Effects of gastric bypass surgery on glucose absorption and metabolism during a mixed meal in glucose-tolerant individuals. Diabetologia. 2013 Oct;56(10):2250-4. doi: 10.1007/s00125-013-3003-0. Epub 2013 Jul 27.

    PMID: 23893303DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood

Central Study Contacts

siv H Jacobsne, MD

CONTACT

+4538626357siv.hesse@hotmail.com

Study Design

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

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Last Updated

March 21, 2012

Record last verified: 2012-03

Locations

DK(2)