Investigating somatostatin secretion patterns using pro-somatostatin 1-64
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
This study is testing how a medication that lowers stomach acid affects the release of a hormone called somatostatin in healthy people.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 11 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 2 sites (Copenhagen, Capital and 1 other locations) |
| Trial ID | NCT06121245 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled, crossover study aims to assess the secretion pattern of somatostatin by measuring plasma concentrations of pro-somatostatin 1-64, a stable peptide released alongside somatostatin. Healthy participants will undergo two study visits where they will take either a proton pump inhibitor or a placebo before consuming a beverage designed to lower stomach pH and stimulate somatostatin release. Blood samples will be collected to evaluate the levels of pro-somatostatin 1-64, providing insights into somatostatin dynamics in humans.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older with stable normal weight and non-diabetic fasting plasma glucose levels.
Not a fit: Patients with significant gastrointestinal symptoms, a history of gastrointestinal disease, or those on medications affecting gastrointestinal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable surrogate marker for somatostatin secretion, enhancing our understanding of gastrointestinal regulation.
How similar studies have performed: While the approach of using pro-somatostatin 1-64 as a marker is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen, Capital and 1 other locations
- University of Copenhagen — Copenhagen, Capital, Denmark (Recruiting)
- Hvidovre University Hospital — Hvidovre, Capital, Denmark (Active_not_recruiting)
Study contacts
- Principal investigator: Jens J Holst, MD — University of Copenhagen
- Study coordinator: Simon Veedfald, MD
- Email: veedfald@sund.ku.dk
- Phone: +45 41102595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.