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OpenTrials
Completed

NCT Number: NCT04055025

Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

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.

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Key information

Conditions

Bariatric Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

Four-hour liquid solid meal tests and a subsequent ad libitum meal during saline infusion.

Ghrelin

Other

Four-hour liquid solid meal tests and a subsequent ad libitum meal during acyl-ghrelin infusion.

Primary outcomes

  1. Ad libitum

    Time frame: 240 minutes

    Ad libitum food intake (gram) with and without infusion of ghrelin at 3 months after LSG surgery

Secondary outcomes

  1. Ad libitum

    Time frame: 240 minutes

    Ad libitum food intake (gram) with and without ghrelin infusion before surgery.

  2. Ghrelin

    Time frame: 240 minutes

    Plasma concentration profile of ghrelin (AUC) before and after LSG.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2019
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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