Status:
COMPLETED
The Effect of Insulin-induced Hypoglycaemia on Gut-derived Glucagon Secretion (Px-Hypo)
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborating Sponsors:
University of Copenhagen
Conditions:
Diabetes After Total Pancreatectomy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 pancrea...
Detailed Description
The investigators want to assess the plasma glucagon response to insulin-induced hypoglycaemia in totally pancreatectomised patients and at the same time evaluate whether hypoglycaemia affects a range...
Eligibility Criteria
Inclusion
- 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
- 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 resection and/or ostomy
- Nephropathy (serum creatinine \>150 µmol/l and/or albuminuria)
- Known liver disease (excluding non-alcoholic fatty liver disease) and/or serum ALAT and/or serum 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
Key Trial Info
Start Date :
July 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04064203
Start Date
July 5 2017
End Date
September 20 2018
Last Update
August 21 2019
Active Locations (1)
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1
Center for Clinical Metabolic Research
Hellerup, Capital Region, Denmark, 2900