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Physiological Effects of Gastric Sleeve Operation

NCT ID: NCT03046186

Last Updated: 2020-11-30

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

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-06-30

Brief Summary

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After gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however to which extent is not fully established and furthermore, the mechanisms behind an altered secretion are unclear. The purpose of this study is to investigate absorption and postprandial metabolism of glucose and protein in addition to gut hormonal responses after gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI. Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI, current BMI, sex and age will be included for comparison.

Detailed Description

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Conditions

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Obesity, Morbid Bariatric Surgery

Keywords

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Gastric sleeve Gastric bypass

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Gastric sleeve operated subjects

12 patients who have undergone gastric sleeve operation \>12 month prior to inclution.

Mixed meal test with double tracer technique

Intervention Type DIAGNOSTIC_TEST

Control Subjects

12 Healthy un-operated control subjects matched to the gastric sleeve group in a one to one manner with respect to BMI, sex and age

Mixed meal test with double tracer technique

Intervention Type DIAGNOSTIC_TEST

Gastric bypass operated subjects

12 patients, who have undergone Roux-en-Y gastric bypass \>12 month prior to inclution, matched to the gastric sleeve group in a one to one manner with respect to pre-operative BMI, post-operative BMI, sex and age.

Mixed meal test with double tracer technique

Intervention Type DIAGNOSTIC_TEST

Interventions

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Mixed meal test with double tracer technique

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Uncomplicated RYGB or SG \> 12 month prior to inclusion
* Weight stable (+/- 3 month the last month)
* Written informed consent


* Written informed consent

Exclusion Criteria

* Diabetes (HbA1c\>48 or Fasting plasma-glucose\>6.1 mM)
* Pregnancy and/or breastfeeding
* Inadequately treated thyroid disease
* Serious heart or respiratory illness
* Haemoglobin \< 6,5 mM.

Un-operated control group:


* Prior RYGB, SG or complicated upper gastrointestinal surgery
* Diabetes (HbA1c\>48 or Fasting plasma-glucose\>6.1 mM)
* Pregnancy and/or breastfeeding
* Inadequately treated thyroid disease
* Serious heart or respiratory illness
* Haemoglobin \< 6,5 mM.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Maria Saur Svane

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hvidovre University Hospital

Hvidovre, Please Select, Denmark

Site Status

Countries

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Denmark

References

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Svane MS, Bojsen-Moller KN, Martinussen C, Dirksen C, Madsen JL, Reitelseder S, Holm L, Rehfeld JF, Kristiansen VB, van Hall G, Holst JJ, Madsbad S. Postprandial Nutrient Handling and Gastrointestinal Hormone Secretion After Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy. Gastroenterology. 2019 May;156(6):1627-1641.e1. doi: 10.1053/j.gastro.2019.01.262. Epub 2019 Feb 8.

Reference Type DERIVED
PMID: 30742833 (View on PubMed)

Other Identifiers

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MS-SGRYGB-15

Identifier Type: -

Identifier Source: org_study_id