CompletedNot Applicable

The Effect of Insulin-induced Hypoglycaemia on Gut-derived Glucagon Secretion (Px-Hypo)

Denmark24 participantsStarted 2017-07-05

Plain-language summary

The overall objective of this study is to investigate whether hypoglycaemia (the most potent stimulus of pancreatic glucagon secretion) affects the secretion of gut-derived glucagon in totally pancreatectomized patients.

Who can participate

Age range

18 Years – 85 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: Pancreatectomised patients * Caucasian above 30 years of age who have undergone total pancreatectomy * Blood haemoglobin \>7.0 mmol/l for males and \>6.5 mmol/l for females Non-diabetic control subjects * Normal fasting plasma glucose and normal HbA1c (according to the World Health Organization (WHO) criteria) * Normal blood haemoglobin * Caucasian above 30 years of age * BMI (body mass index) 17-30 * Informed consent Exclusion Criteria: Pancreatectomised patients * Pancreatectomy within the last 3 months * Ongoing chemotherapy or chemotherapy within the last 3 months * Previous or ongoing treatment with GLP-1 receptor agonists or dipeptidyl peptidase 4 (DPP-4) inhibitors * Inflammatory bowel disease * Gastrointestinal resection (other than the gastro-duodenectomy performed in connection with total pancreatectomy) and/or ostomy * Nephropathy (eGFR\<60 and/or albuminuria) * Known liver disease (excluding non-alcoholic fatty liver disease) and/or serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>3 × normal values) * Severe lung disease * Pregnancy and/or breastfeeding * Age above 85 years * Uncontrolled hypertension and/or significant cardiovascular disease * Any condition that the investigator feels would interfere with trial participation Non-diabetic control subjects * Diabetes or prediabetes (according to WHO criteria) * First-degree relatives with diabetes * Inflammatory bowel disease * Gastrointestinal resectio…

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

p-glucagon

Timeframe: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes

Trial details

NCT IDNCT04064203

SponsorUniversity Hospital, Gentofte, Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-20

View on ClinicalTrials.gov More Diabetes After Total Pancreatectomy trials

Who can participate

Age range

18 Years – 85 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.