Physiological Effects of Gastric Sleeve Operation

Study Overview
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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.

Official Title
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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

Conditions
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Obesity, Morbid, Bariatric Surgery

Intervention / Treatment
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* Diagnostic Test: Mixed meal test with double tracer technique


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric sleeve operated subjects<br>12 patients who have undergone gastric sleeve operation >12 month prior to inclution. | Diagnostic Test: Mixed meal test with double tracer technique<br> <br> |
| Control Subjects<br>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 | Diagnostic Test: Mixed meal test with double tracer technique<br> <br> |
| Gastric bypass operated subjects<br>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. | Diagnostic Test: Mixed meal test with double tracer technique<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose absorption | Between groups difference in peak Rate of appearance (Ra) of oral glucose tracer SG vs. CON | 0 - 360 minutes | 
| Protein absorption | Between groups difference in peak Ra of oral aminoacid tracer SG vs. CON | 0 - 360 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric sleeve, Gastric bypass