Status:
UNKNOWN
The PRO-SOma COla (PROSOCO) Study
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Hvidovre University Hospital
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
Detailed 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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06121245
Start Date
September 13 2023
End Date
February 1 2024
Last Update
November 7 2023
Active Locations (2)
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1
University of Copenhagen
Copenhagen, Capital, Denmark, 2200
2
Hvidovre University Hospital
Hvidovre, Capital, Denmark, 2650