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Physiological Effects of Gastric Sleeve Operation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03046186
Enrollment
36
Registered
2017-02-08
Start date
2016-06-30
Completion date
2017-06-30
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Obesity, Morbid

Keywords

Gastric sleeve, Gastric bypass

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.

Interventions

DIAGNOSTIC_TESTMixed meal test with double tracer technique

Sponsors

University of Copenhagen
CollaboratorOTHER
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Glucose absorption0 - 360 minutesBetween groups difference in peak Rate of appearance (Ra) of oral glucose tracer SG vs. CON
Protein absorption0 - 360 minutesBetween groups difference in peak Ra of oral aminoacid tracer SG vs. CON

Secondary

MeasureTime frameDescription
Glucose kinetics0 - 360 minutesBetween groups differences in AUC Ra of oral glucose tracer
Protein kinetics0 - 360 minutesBetween groups differences in AUC Ra of oral aminoacid tracer
Insulin secretion0 - 240 minutesBetween groups differences in iAUC of serum insulin and C-peptide
Glucagon-like Peptide 1 (GLP-1) secretion0 - 240 minutesBetween groups differences in iAUC of plasma concentration of GLP-1
Glucose-dependent Insulinotropic Peptide (GIP)0 - 240 minutesBetween groups differences in iAUC of plasma concentration of GIP
Glucose absorption0 - 360 minutesBetween group difference in peak Ra of oral glucose comparing SG vs. RYGB
Glucagon secretion0-240 minutesBetween groups differences in iAUC of plasma cncentration of glucagon
Peptide YY0-240 minutesBetween groups differences in iAUC of plasma concentration of PYY
Endogenous glucose production-120 - 360 minutesCalculated via double tracer tecnique both in the fasting and post prandial state.
Lipolysis-120 - 360Between groups differences in Rate of Disappearance of glycerol tracer.
Ghrelin secretion0 - 240 minutesBetween groups differences in iAUC of plasma concentration of ghrelin
Protein absorption0 - 360 minutesBetween groups differences in peak Ra of oral aminoacid tracer comparing SG vs. RYGB

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026