CompletedNot Applicable

Gastrointestinal Hormone Secretion, Intestinal Permeability and Short Bowel Syndrome

Denmark39 participantsStarted 2021-06-01

Plain-language summary

The gastrointestinal tract is a complex endocrine organ that regulates a wide range of physiological processes, including those involved in the digestion of nutrients. These processes are dynamically coordinated by specialized cells within the intestinal epithelium which, upon exposure to luminal nutrients, secrete a variety of enteroendocrine hormones, such as Gastrin, Cholecystokinin, Glucose-dependent insulinotropic peptide, Neurotensin, Glucagon-like peptide 1, Glucagon-like peptide 2, and Peptide YY. In this study, we aim to investigate how resection of different intestinal segments affects fasting and postprandial secretion of these gut hormones, and to characterize how these secretion profiles differ compared with healthy controls. Patients with a history of intestinal resection will be included and stratified according to the intestinal segments in continuity at the time of study participation into the following anatomical groups: * Group 1A: Patients with jejunum only in continuity and a total small bowel length \<150 cm. * Group 1B: Patients with an ileostomy and a maximum resection of 30 cm of the terminal ileum. The colon is not in continuity, and the ileocecal valve is also not in continuity. * Group 2: Patients with \<150 cm jejunum anastomosed to the ascending colon or proximally in the transverse colon. * Group 3: Patients with a jejuno-ileal anastomosis, an intact ileocecal valve, and the entire colon in continuity. In addition, healthy control subjects will be included to enable comparison between patient groups and normal physiology. Fasting blood samples will be obtained after a standardized rest period, after which all participants will ingest a standardized meal within 15 minutes. Subsequently, repeated blood samples will be collected at t = 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes postprandially. Differences between groups in fasting values, area-under-the-curve (AUC), and incremental AUC, values will be calculated. Differences between anatomical groups will be analyzed using analysis of variance (ANOVA) on log-transformed data to improve model fit. Correlations between the secretion profiles of different enteroendocrine hormones will be assessed using Pearson's r.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Having any history of resection of small intestine. Information regarding remnant bowel anatomy will be based on data obtained from patient medical records. * At least 6 months since last intestinal resection. * If diagnosed with liver cirrhosis, patients should score a maximum of 12 points on the Child-Pugh scoring system (corresponds to Child-Pugh C with a maximum of 12 points). Patients scoring more than 12 points are considered to have terminal cirrhosis and will be excluded from the study. It is likely that terminally cirrhotic patients have concurrent disease processes that could influence results. * Age between 18 years and 80 years (both included) * BMI between 16 and 30 (both included) * Able to ingest a standardized meal containing 2841 kJ (679 kcal). The meal consisted of 21 g protein, 78 g carbohydrate, and 31 g fat, corresponding to a macronutrient distribution of 13% protein, 46% carbohydrate, and 41% fat. It included 50 g rye bread, 50 g coarse bread, 32 g butter, 40 g cheese (45+), 20 g jam, 150 g fruit yogurt, 100 g banana, and 200 g water Healthy controls subjects: * Not diagnosed with any chronic or acute disease * BMI between 16 and 30 (both included) * Negative pregnancy test (plasma hCG) for women of childbearing potential (at screening visit) * Age between 18 years and 80 years (both included) * Able to ingest the meal presented in inclusion criteria no. 6. Exclusion Criteria: * Over hepatic encephalopathy. * Cholangiocarcinom…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fasting and postprandial levels of entero-endocrine hormones

Timeframe: 255 minutes

Trial details

NCT IDNCT07235670

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-16

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