The PRO-SOma COla (PROSOCO) Study

Healthy Clinical Trial

— PROSOCO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06121245
• Other study ID #: PROSOCO
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: February 2024

Study information

• Verified date: November 2023
• Source: University of Copenhagen
• Contact: Simon Veedfald, MD
• Phone: +45 41102595
• Email: veedfald[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11
• Est. completion date: February 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age = 18 years

• Non-diabetic fasting plasma glucose (< 7.0 mmol/L) at time of inclusion

• Normal weight and weight stable

• Written informed consent

Exclusion Criteria:

• Pregnancy or breastfeeding

• Haemoglobin < 7.9 mmol/L

• Prior gastrointestinal operations excluding uncomplicated appendectomy

• Significant gastrointestinal symptoms (e.g. dyspepsia, postprandial pain)

• Intolerance to aspartame

• Use of medication that may influence blood pressure, gastrointestinal motor function, body weight or appetite (e.g. antihypertensive drugs, anticholinergic drugs (e.g. atropine, hyoscine), prokinetic drugs (metoclopramide, domperidone, erythromycin), orlistat, green tea extracts, astragalus, St. John's Wort etc.)

• Evidence of drug abuse, consumption of tobacco in any form or daily consumption of more than 20g alcohol

• History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery including cholecystectomy (but not uncomplicated appendectomy) Participation in any other research studies within the previous 3 months

• Inability to give informed consent

• Non-Probability Sample: Any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Proton Pump inhibitor
A proton pump inhibitor will be used as a tool to study the effect of pH changes in the stomach lumen on the release of somatostatin (evaluated by measurements of somatostatin and pro-somatostatin 1-64)
• Placebo
Placebo capsule

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen	Capital
Denmark	Hvidovre University Hospital	Hvidovre	Capital

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of pro-somatostatin 1-64	Peptide released from D-cells in the gut in equimolar concentrations alongside somatostatin	baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Secondary	Plasma concentration of gastrin	peptide hormone released from G cells in the antrum of the stomach	baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Secondary	Plasma concentration of cholecystokinin	peptide hormone released from I cells in the proximal small intestine	baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Secondary	Plasma concentration of secretin	Peptide hormone released from S cells in the small intestine	baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Secondary	Plasma concentration of pancreatic polypeptide	Peptide hormone released from the endocrine pancreas	baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Secondary	Plasma concentration of glucose		baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min