Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5402
Source ID: NCT05095259
Associated Drug: Insulin Human
Title: Metabolic Adaptation to High-frequent Hypoglycaemia in Type 1 Diabetes
Acronym: HypoADAPT
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type1diabetes
Interventions: DRUG: insulin human|DRUG: Epinephrin|PROCEDURE: Muscle biopsy|PROCEDURE: Adipose tissue biopsy|DRUG: Glucagon|DEVICE: IPRO 2 Medtronic Minimed|PROCEDURE: 7 Tesla (7T) Magnetic Resonance Imaging|PROCEDURE: Indirect Calorimetry using Jaeger Oxycon Champion|PROCEDURE: Core temperature and thermography using Thermovision SC645|DEVICE: Freestyle Libre 2
Outcome Measures: Primary: Metabolite- and lipid profiling, Metabolite- and lipid profiling of blood samples using metabolomics profiling platforms during euglycaemia, 5 minutes|Brain lactate concentration, Brain lactate concentration using non-invasive magnetic resonance (MR) spectroscopy during euglycaemia, 20 minutes|Brain adenosine triphosphate (ATP) concentration, Brain ATP concentration using non-invasive MR spectroscopy during euglycaemia, 20 minutes|Glycogen in muscle and adipose tissue, Glycogen in muscle and adipose tissue biopsies during euglycaemia, 5 minutes|Non-specific proteins in muscle and adipose tissue, Non-specific proteins in muscle and adipose tissue biopsies during euglycaemia, 5 minutes|Glycogen concentration, Glycogen in liver and muscle tissue using non-invasive MR spectroscopy during euglycaemia., 40 minutes | Secondary: Estimated glucose production during glucagon stimulation, Area under the curve (AUC) for plasma glucose during glucagon injections. Plasma glucose measurement, Every 5 minutes up to 5 hours|Estimated glucose production during epinephrine stimulation, Area under the curve (AUC) for plasma glucose during epinephrine infusion. Plasma glucose measurement, Every 5 minutes up to 90 minutes|Indirect calorimetry, Estimating resting metabolic rate, before and during hyperinsulinemic-hypoglycemic clamp, 60 minutes|Thermography, Estimating skin temperature, before and during hyperinsulinemic-hypoglycemic clamp, 5 minutes|Plasma lactate during glucagon injections., Plasma lactate during glucagon injections., Every 40 minutes up to 5 hours|Plasma free fatty acids during glucagon injections., Plasma free fatty acids during glucagon injections., Every 40 minutes up to 5 hours|Plasma glycerol during glucagon injections., Plasma glycerol during glucagon injections., Every 40 minutes up to 5 hours|Plasma alanine during glucagon injections., Plasma alanine during glucagon injections., Every 40 minutes up to 5 hours|Plasma β-hydroxybutyrate during glucagon injections., Plasma β-hydroxybutyrate during glucagon injections., Every 40 minutes up to 5 hours|Plasma insulin during glucagon injections., Plasma insulin during glucagon injections., Every 40 minutes up to 5 hours|Plasma glucagon during glucagon injections., Plasma glucagon during glucagon injections., Every 40 minutes up to 5 hours|Plasma metabolomics during glucagon injections., Plasma metabolomics during glucagon injections., Every 40 minutes up to 5 hours|Plasma lactate during epinephrine infusion, Plasma lactate during epinephrine infusion, Every 20 minutes up to 90 minutes|Plasma free fatty acids during epinephrine infusion, Plasma free fatty acids during epinephrine infusion, Every 20 minutes up to 90 minutes|Plasma glycerol during epinephrine infusion, Plasma glycerol during epinephrine infusion, Every 20 minutes up to 90 minutes|Plasma alanine during epinephrine infusion, Plasma alanine during epinephrine infusion, Every 20 minutes up to 90 minutes|Plasma β-hydroxybutyrate during epinephrine infusion, Plasma β-hydroxybutyrate during epinephrine infusion, Every 20 minutes up to 90 minutes|Plasma insulin during epinephrine infusion, Plasma insulin during epinephrine infusion, Every 20 minutes up to 90 minutes|Plasma glucagon during epinephrine infusion, Plasma glucagon during epinephrine infusion, Every 20 minutes up to 90 minutes|Plasma epinephrine during epinephrine infusion, Plasma catecholamines during epinephrine infusion, Every 20 minutes up to 90 minutes|Plasma norepinephrine during epinephrine infusion, Plasma catecholamines during epinephrine infusion, Every 20 minutes up to 90 minutes|Plasma metabolomics during epinephrine infusion, Plasma metabolomics during epinephrine infusion, Every 20 minutes up to 90 minutes|Personality traits using the psychometry questionnaire Type D Scale-14 (DS-14), Personality traits using the psychometry questionnaire DS-14, score between 0-28, the higher, the more likely they have type D personality, 30 minutes|Personality traits using the psychometry questionnaire Toronto Alexithymia Scale (TAS-20), Personality traits using the psychometry questionnaire TAS-20, score 20-100, the higher score the more likely they are alexithymia, 30 minutes|Diabetes and hypoglycaemia status using psychometry questionnaire Hypoglycemia Fear Survey - Worry (HFS-W), Diabetes and hypoglycaemia status using psychometry questionnaire HFS-W, score 0-72, the higher score the higher fear for hypoglycemia, 30 minutes|Diabetes and hypoglycaemia status using psychometry questionnaire Hypoglycemia Attitudes and Behavior Scale (HABS), Diabetes and hypoglycaemia status using psychometry questionnaire HABS, score from 14-45, higher score more fear of hypoglycemia, 30 minutes|Diabetes and hypoglycaemia status using psychometry questionnaire Problem Areas in Diabetes (PAID), Diabetes and hypoglycaemia status using psychometry questionnaire PAID, 0-80, the higher score, the more problems with diabetes, 30 minutes|Food consumption, Using Food Frequency Questionnaire to analyze food consumption, 30 minutes|Hypoglycemia awareness status, Using hypoglycemia awareness status questionnaire , 0-7, higher score indicate hypoglycemia unawareness, 10 minutes
Sponsor/Collaborators: Sponsor: Nordsjaellands Hospital | Collaborators: Danish Research Centre for Magnetic Resonance|University of Copenhagen|Steno Diabetes Center Copenhagen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2019-12-16
Completion Date: 2023-12
Results First Posted:
Last Update Posted: 2023-05-03
Locations: Steno Diabetes Center Copenhagen, Gentofte, 2820, Denmark|Nordsjaellands Hospital, Hillerød, 3400, Denmark
URL: https://clinicaltrials.gov/show/NCT05095259