Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study

NCT ID: NCT02161666

Last Updated: 2015-04-07

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

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-12-31

Brief Summary

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To examine pancreatic islet function and incretin function during intravenous and oral stimulation \>2 years after gastric bypass surgery in patients with normal glucose tolerance. We hypothesize that islet cell and incretin function is enhanced in response to oral, but not intravenous, stimulation - i.e. incretin released from the gut in response to oral stimulation play a key role for the enhanced islet function after gastric bypass surgery.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Morbidly obese patients with normal glucose tolerance undergoing gastric bypass surgery

No interventions assigned to this group

Controls

Age, sex and BMI-matched healthy controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participation in previous study (NCT01559779)

Exclusion Criteria

* Pregnancy/lactation
* Major chronic disease develop since previous examination with possible impact on outcomes
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Carsten Dirksen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carsten Dirksen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Hvidovre, Danmark, Denmark

Site Status

Countries

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Denmark

References

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Dirksen C, Eiken A, Bojsen-Moller KN, Svane MS, Martinussen C, Jorgensen NB, Holst JJ, Madsbad S. No Islet Cell Hyperfunction, but Altered Gut-Islet Regulation and Postprandial Hypoglycemia in Glucose-Tolerant Patients 3 Years After Gastric Bypass Surgery. Obes Surg. 2016 Sep;26(9):2263-2267. doi: 10.1007/s11695-016-2197-x.

Reference Type DERIVED
PMID: 27138601 (View on PubMed)

Other Identifiers

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AB-CD-10-2Y

Identifier Type: -

Identifier Source: org_study_id

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