The Effect of Insulin-induced Hypoglycaemia on Gut-derived Glucagon Secretion (Px-Hypo)
NCT ID: NCT04064203
Last Updated: 2019-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2017-07-05
2018-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Totally pancreatectomized patients
Oral glucose tolerance test + insulin-induced hypoglycaemic clamp followed by an oral glucose tolerance test
Oral glucose tolerance test
50 grams OGTT
Clamp experiment
insulin-induced hypoglycaemic clamp followed by an 50 grams OGTT
Healthy controls
Oral glucose tolerance test + insulin-induced hypoglycaemic clamp followed by an oral glucose tolerance test
Oral glucose tolerance test
50 grams OGTT
Clamp experiment
insulin-induced hypoglycaemic clamp followed by an 50 grams OGTT
Interventions
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Oral glucose tolerance test
50 grams OGTT
Clamp experiment
insulin-induced hypoglycaemic clamp followed by an 50 grams OGTT
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
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Filip Krag Knop
Consultant endocrinologist, Professor of
Locations
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Center for Clinical Metabolic Research
Hellerup, Capital Region, Denmark
Countries
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Other Identifiers
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H-17014216
Identifier Type: -
Identifier Source: org_study_id
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