The PRO-SOma COla (PROSOCO) Study — PROSOCO  

Healthy Clinical Trial

Official title: Evaluating the Release of the Entero-pancreatic Hormone Somatostatin by Measuring Stable Co-secreted Prosomatostatin Moieties in the Plasma of Healthy Individuals - the PRO-SOma COla (PROSOCO) Study

Status Recruiting

Clinical Trial Summary

The goal of this randomized, double-blind, placebo-controlled, crossover study is to determine whether it is possible to gauge the pattern of somatostatin secretion by measuring plasma concentrations of pro-somatostatin 1-64 (a stable peptide that is released in equimolar amounts alongside somatostatin) as a surrogate marker. During the study the release of somatostatin will be manipulated by changing the luminal pH of the stomach.

Healthy participants will be studied in a randomized on two occasions. The day before both two study visits participants will ingest a capsule in the morning and a capsule in the evening. On one day the capsule will contain a proton pump inhibitor (Esomeprazol) to elevate the luminal pH of the stomach and on the other day the capsule will be a placebo. On the study days participants will ingest, in the mornng after an overnight fast, a coca cola zero + lemon juice to lower the luminal pH which willelicit the release of somatostatin. Blood samples will be collected before and after the ingestion of coca cola.

Clinical Trial Description

Somatostatin is a polypeptide that plays a key regulatory role in the gastrointestinal tract and pancreas. It has been attempted to determine in peripheral plasma samples the pattern of somatostatin release. However, due to the brief half-life of somatostatin this it turns out is difficult. Therefore, the investigators have developed an antibodies and a radioimmunoassay that measures concentrations of a stable peptide termed prosomatostatin 1-64. This peptide is released in equimolar amounts alongside somatostatin from the somatostatin-producing cells in the gut.

The current study aims to demonstrate that prosomatostatin 1-64 can be picked up in peripheral plasma from human study participants. The release of somatostatin is increased when the pH of the stomach is low. The release of somatostatin will be elicited by asking participants coca cola zero with lemon juice. Participants will be studied on two occasions (on one day participants will be pretreated with a proton pump inhibitor, on the other day with a placebo). The two visits will be carried out as a placebo-controlled crossover study following a randomised schedule.

If successful, pro-somatostatin 1-64 can be as a surrogate marker of somatostatin secretion. This will allow investigations of somatostatin secretion dynamics in humans. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT06121245
• Study type: Interventional
• Source: University of Copenhagen
• Contact: Simon Veedfald, MD
• Phone: +45 41102595
• Email: veedfald@sund.ku.dk
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Completion date: February 2024