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
10 participants
INTERVENTIONAL
2022-12-06
2024-09-25
Brief Summary
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• What are the physiological effects of the naturally occuring hormone NST - especially with regards to glucagonotropic effects at different plasma glucose concentrations
In a randomized, double-blind crossover design, participants will undergo six experimental days with controlled plasma glucose levels, consisting of two euglycemic, two hyperglycemic (around 8mmol/l), and two hypoglycemic (around 2.5mmol/l) days, with each pair of similar days involving the administration of either saline (placebo) or NST.
Detailed Description
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After being informed about the study and the potential risks, each participant giving written informed consent will participate in six double-blinded experimental days (Day A-F) in a randomized order. On each day, participants will receive an infusion of either saline (placebo)(day A, C and E) or NST (day B, D and F). On day A and B, blood glucose will be kept at fasting levels, on day C and D blood glucose will be increased to \~8mmol/l and on day E and F blood glucose will be lowered to \~2.5mmol/l.
Blood glucose will be adjusted with insulin and/or glucose to reach the desired levels on each day.
At the end of the study day, participants will receive an ad libitum meal.
The effects of each infusion will be evaluated with regards to glucagonotropic potency, as well as a series of exploratory outcomes.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Infusion of NST or placebo at different blood glucose levels
In a randomized, double-blind crossover design, participants will undergo six experimental days with controlled plasma glucose levels, consisting of two euglycemic, two hyperglycemic (around 8mmol/l), and two hypoglycemic (around 2.5mmol/l) days, with each pair of similar days involving the administration of either saline (placebo) or NST.
Infusion of either NST or placebo at different blood glucose levels
In a randomized, double-blind crossover design, participants will undergo six experimental days with controlled plasma glucose levels, consisting of two euglycemic, two hyperglycemic (around 8mmol/l), and two hypoglycemic (around 2.5mmol/l) days, with each pair of similar days involving the administration of either saline (placebo) or NST.
Interventions
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Infusion of either NST or placebo at different blood glucose levels
In a randomized, double-blind crossover design, participants will undergo six experimental days with controlled plasma glucose levels, consisting of two euglycemic, two hyperglycemic (around 8mmol/l), and two hypoglycemic (around 2.5mmol/l) days, with each pair of similar days involving the administration of either saline (placebo) or NST.
Eligibility Criteria
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Inclusion Criteria
* Normal fasting plasma glucose below 7 mmol/l
* Normal HbA1C \<42 mmol/mol (6%)
* Body mass index (BMI) 18.5-27 kg/m2
* Oral and written informed consent
Exclusion Criteria
* Treatment with drugs that might interfere with glucose metabolism within a month prior to the research study
* Treatment with any medication that cannot be paused for 12 hours
* Known liver disease and/or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 × normal values
* Nephropathy (eGFR \<60 ml/min and/or albuminuria)
* Any condition that the investigator feels would interfere with trial participation
18 Years
65 Years
MALE
Yes
Sponsors
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The Novo Nordisk Foundation Center for Basic Metabolic Research
OTHER
University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
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Asger Lund, MD
MD
Locations
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Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, , Denmark
Countries
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Other Identifiers
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NSTCLAMP
Identifier Type: -
Identifier Source: org_study_id