Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

Study Overview
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Brief Summary
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Our hypothesis is that decreased concentration of ghrelin after LSG is important for the decreased appetite and food intake postoperatively. We therefore expect infusion of ghrelin will increase an ad libitum food intake after LSG. We also expect that a decreased postprandial concentration of ghrelin after LSG play a role for increased insulin secretion and decreased postprandial plasma glucose concentrations after surgery.

Detailed Description
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Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are to bariatric procedure. After both procedures, a changed secretion of hormones from the gastrointestinal tract is believed to affect appetite and glucose metabolism. Studies have shown that after LRYGB, there is a significant increased secretion of GLP-1 and PYY. In contrast, a decreased secretion of ghrelin is a characteristic finding after LSG opposite post-LRYGB, where secretion of ghrelin is reported to be increased, decreased or unchanged. Ghrelin is primarily secreted from the gastric mucosa in the fasting state and decreases in response to food intake. Ghrelin stimulates food intake through appetite-regulating centers in the hypothalamus. Administration of exogenous ghrelin has been reported to stimulate appetite. In addition, ghrelin has recently been suggested also to affect glucose metabolism by inhibition of glucose-stimulated insulin secretion. Therefore the markedly decreased secretion of ghrelin could be of particular important for the decreased appetite and improved glucose tolerance seen after LSG.

Official Title
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Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

Conditions
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Bariatric Surgery

Intervention / Treatment
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* Other: Placebo
* Other: Ghrelin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The Danish national inclusion criteria for bariatric surgery Signed written informed consent Fasting plasma glucose <6.1 mmol/l Exclusion Criteria: Pregnancy or breastfeeding. Hemoglobin <6.5 mM Newly emerged serious disease

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sleeve gastrectomy operated patients<br>Six test days in a randomized, patient-blinded, cross-over design | Other: Placebo<br>* Four-hour liquid solid meal tests and a subsequent ad libitum meal during saline infusion.<br>Other: Ghrelin<br>* Four-hour liquid solid meal tests and a subsequent ad libitum meal during acyl-ghrelin infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ad libitum | Ad libitum food intake (gram) with and without infusion of ghrelin at 3 months after LSG surgery | 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ad libitum | Ad libitum food intake (gram) with and without ghrelin infusion before surgery. | 240 minutes | 
| Ghrelin | Plasma concentration profile of ghrelin (AUC) before and after LSG. | 240 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ghrelin, Sleeve gastrectomy, Laparoscopic sleeve gastrectomy