Clinical trial NCT03046186: Physiological Effects of Gastric Sleeve Operation
Official title: Effect of Gastric Sleeve Operation on Absorption and Metabolism of Glucose and Protein as Well as Gut-hormonal Response - A Comparison With Roux-en-Y Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Bariatric Surgery
Keywords: Gastric sleeve
Gastric bypass
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2017-02-08
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, who have undergone Roux-en-Y gastric bypass OR gastric sleeve operation \> 12 month prior to inclusion.

Matched un-operated control subjects.

Brief summary: 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.


Eligibility criteria: SG ang RYGB group:

Inclusion Criteria:

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

Inclusion Criteria:

* Written informed consent

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Glucose absorption
timeFrame: 0 - 360 minutes
measure: Protein absorption
timeFrame: 0 - 360 minutes
Secondary outcomes:
measure: Glucose absorption
timeFrame: 0 - 360 minutes
measure: Protein absorption
timeFrame: 0 - 360 minutes
measure: Glucose kinetics
timeFrame: 0 - 360 minutes
measure: Protein kinetics
timeFrame: 0 - 360 minutes
measure: Insulin secretion
timeFrame: 0 - 240 minutes
measure: Glucagon-like Peptide 1 (GLP-1) secretion
timeFrame: 0 - 240 minutes
measure: Glucose-dependent Insulinotropic Peptide (GIP)
timeFrame: 0 - 240 minutes
measure: Ghrelin secretion
timeFrame: 0 - 240 minutes
measure: Glucagon secretion
timeFrame: 0-240 minutes
measure: Peptide YY
timeFrame: 0-240 minutes
measure: Endogenous glucose production
timeFrame: -120 - 360 minutes
measure: Lipolysis
timeFrame: -120 - 360
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Please Select
Study officials:
References:
citation: 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.