Physiological Effects of Gastric Sleeve Operation

Completed

• Conditions: Bariatric Surgery; Obesity, Morbid
• Interventions: Diagnostic Test: Mixed meal test with double tracer technique

• Registration Number: NCT03046186
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-08
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastric sleeve operated subjects	Mixed meal test with double tracer technique	12 patients who have undergone gastric sleeve operation \>12 month prior to inclution.
Control Subjects	Mixed meal test with double tracer technique	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
Gastric bypass operated subjects	Mixed meal test with double tracer technique	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.

Primary Outcome Measures

Name	Time	Method
Glucose absorption	0 - 360 minutes	Between groups difference in peak Rate of appearance (Ra) of oral glucose tracer SG vs. CON
Protein absorption	0 - 360 minutes	Between groups difference in peak Ra of oral aminoacid tracer SG vs. CON

Secondary Outcome Measures

Name	Time	Method
Protein kinetics	0 - 360 minutes	Between groups differences in AUC Ra of oral aminoacid tracer
Glucagon-like Peptide 1 (GLP-1) secretion	0 - 240 minutes	Between groups differences in iAUC of plasma concentration of GLP-1
Peptide YY	0-240 minutes	Between groups differences in iAUC of plasma concentration of PYY
Endogenous glucose production	-120 - 360 minutes	Calculated via double tracer tecnique both in the fasting and post prandial state.
Glucose absorption	0 - 360 minutes	Between group difference in peak Ra of oral glucose comparing SG vs. RYGB
Insulin secretion	0 - 240 minutes	Between groups differences in iAUC of serum insulin and C-peptide
Glucose-dependent Insulinotropic Peptide (GIP)	0 - 240 minutes	Between groups differences in iAUC of plasma concentration of GIP
Ghrelin secretion	0 - 240 minutes	Between groups differences in iAUC of plasma concentration of ghrelin
Lipolysis	-120 - 360	Between groups differences in Rate of Disappearance of glycerol tracer.
Protein absorption	0 - 360 minutes	Between groups differences in peak Ra of oral aminoacid tracer comparing SG vs. RYGB
Glucagon secretion	0-240 minutes	Between groups differences in iAUC of plasma cncentration of glucagon
Glucose kinetics	0 - 360 minutes	Between groups differences in AUC Ra of oral glucose tracer

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Please Select, Denmark