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O estudo clínico NCT05095259 (HypoADAPT) para Diabetes tipo 1 está desconhecido. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Metabolic Adaptation to High-frequent Hypoglycaemia in Type 1 Diabetes (HypoADAPT) 60
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT05095259 (HypoADAPT) é um estudo intervencionista para Diabetes tipo 1. Seu status atual é: desconhecido. O estudo começou em 16 de dezembro de 2019 e pretende incluir 60 participantes. Coordenado por Nordsjaellands Hospital e deve ser concluído em 1 de dezembro de 2023. Essas informações foram atualizadas no ClinicalTrials.gov em 3 de maio de 2023.
Resumo
An experimental mechanistic study. The overall objective is to gain new knowledge about mechanisms involved in adaptation to recurrent hypoglycaemia in diabetes by investigating patients with type 1 diabetes and healthy controls. The knowledge to be obtained may feed into experimental hypoglycaemic clamp studies to further elucidate the effect of the adaptations during acute hypoglycaemia. Ultimately, it may lead to ...Mostrar mais
Descrição detalhada
Study rationale The risk of severe hypoglycaemia is a major daily concern for people with diabetes treated with insulin. Severe hypoglycaemia is the main barrier in achieving the recommended glycaemic targets and may indirectly be the main driver for late diabetic complications and related morbidity, mortality and health care costs. In people with diabetes, recurrent exposure to insulin-induced mild hypoglycaemia lea...Mostrar mais
Título oficial
Metabolic Adaptation to High-frequent Hypoglycaemia in Type 1 Diabetes - the HypoADAPT Study
Condições médicas
Diabetes tipo 1Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- HypoADAPT
- DRCMR7T-06
- 2019-001938-34 (Número EudraCT)
Número NCT
Data de início (real)
2019-12-16
Última atualização postada
2023-05-03
Data de conclusão (estimada)
2023-12
Inscrição (estimada)
60
Tipo de estudo
Intervencionista
FASE
N/A
Status
Desconhecido
Palavras-chave
Diabetes Complications
Hypoglycemia
Metabolism
Hypoglycemia
Metabolism
Propósito principal
Ciência básica
Alocação do design
Não randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalParticipants with Type 1 Diabetes Mellitus Participants with Type 1 Diabetes Mellitus | insulin human Hyperinsulinemic glucose clamp studies require that insulin is administered at a steady continuous rate to achieve stable levels of hyperinsulinemia. To reach this, insulin needs to be infused intravenously using a standard intravenous pump system. The insulin dose will be adjusted according to the body surface area, aiming for insulin levels of \~170 mIU/l, which is within the physiological range. Thus, for a subjec...Mostrar mais Epinephrin Epinephrine are prepared in 100 ml isotone saline solution according to weight and infused in 3 different infusion rates: 10 ng∙kg-1∙min-1, 25 ng∙kg-1∙min-1 and 50 ng∙kg-1∙min-1, for 20 minutes each. After each adrenaline infusion, substrate response will be measured by blood samples of glucose, lactate, free fatty acids, alanine, β-hydroxybutyrate, glycerol and insulin. Furthermore, cardiovascular measurements such ...Mostrar mais Biópsia muscular With the study subject resting in the supine position, the skin is disinfected on the lateral side of the thigh around 15 cm above the knee, with chlorhexidine alcohol. Then 3-4 mL of local anaesthetic (lidocaine 20 mg/mL) is injected into the skin, subcutaneous tissue and in the upper part of the muscle with a very thin needle. When the anaesthetic effect has set in after a couple of minutes an insertion is made in ...Mostrar mais Biópsia de tecido adiposo With the study subject resting in the supine position, the skin is disinfected on one side of the abdomen around 5-10 cm lateral from the umbilicus to the knee, with chlorhexidine alcohol. Then 3-4 mL of local anaesthetic (lidocaine 20 mg/mL) is injected into the skin, subcutaneous tissue and in the upper part of the adipose tissue with a very thin needle. When the anaesthetic effect has set in after a couple of minu...Mostrar mais Glucagon Glucagon is prepared in doses of 10 µg, 25 µg, and 50 µg and intravenously injected with intervals of 2 hours. After each glucagon injection, blood samples will be drawn to measure plasma glucose, glucagon, lactate, free fatty acids, alanine, amino-acids, β-hydroxybutyrate, glycerol and insulin. Furthermore, cardiovascular measurements such as pulse and blood pressure are monitored as well. IPRO 2 Medtronic Minimed All potential subjects will receive a blinded continuous glucose sensor at Visit 1. At the following visits, the continuous glucose monitor (CGM) will be reviewed for hypoglycaemia episodes and replaced at the same time. At Visit 2 a final screening of the inclusion criteria will take place, which involves the CGM data of the first week. A blinded CGM will be installed a week before every visit. 7 Tesla (7T) Magnetic Resonance Imaging Subjects will undergo a hyperinsulinemic euglycaemic glucose clamp, as mentioned above, in the MRI scanning room. After 30 minutes of stable normoglycaemia, subjects are taken into the MRI scanner (Philips Achieva 7.0 T) where brain, liver, thigh and calf muscle are scanned. After every anatomically different area, the subjects must be taken out of the scanner, while scanning coils are replaced. All subjects are advi...Mostrar mais Indirect Calorimetry using Jaeger Oxycon Champion Resting metabolic rate will be estimated, after reaching stable plasma glucose level, via a hyperinsulinemic euglycaemic clamp, as mentioned above. This will be done by indirect calorimetry, using a ventilated hood system (Jaeger Oxycon Champion, software version 4.3, Jaeger, Mijnhardt). Subjects are instructed to lie down and rest for a period of 30 minutes. Subjects are also instructed not to move, talk or sleep un...Mostrar mais Core temperature and thermography using Thermovision SC645 Thermography (Thermovision SC645, FLIR Systems, Wilsonville, OR, USA) is used to determine cutaneous vascular perfusion. Data is analogue-digital converted and sampled at 100 Hz (Powerlab, ADInstruments, Colorado Springs, CO, USA). Freestyle Libre 2 All potential subjects will receive a continuous glucose sensor at Visit 1. At the following visits, the CGM will be reviewed for hypoglycaemia episodes and replaced at the same time. At Visit 2 a final screening of the inclusion criteria will take place, which involves the CGM data of the first week. A CGM will be installed a week before every visit. |
Comparador ativoHealthy Controls Healthy Controls | insulin human Hyperinsulinemic glucose clamp studies require that insulin is administered at a steady continuous rate to achieve stable levels of hyperinsulinemia. To reach this, insulin needs to be infused intravenously using a standard intravenous pump system. The insulin dose will be adjusted according to the body surface area, aiming for insulin levels of \~170 mIU/l, which is within the physiological range. Thus, for a subjec...Mostrar mais Epinephrin Epinephrine are prepared in 100 ml isotone saline solution according to weight and infused in 3 different infusion rates: 10 ng∙kg-1∙min-1, 25 ng∙kg-1∙min-1 and 50 ng∙kg-1∙min-1, for 20 minutes each. After each adrenaline infusion, substrate response will be measured by blood samples of glucose, lactate, free fatty acids, alanine, β-hydroxybutyrate, glycerol and insulin. Furthermore, cardiovascular measurements such ...Mostrar mais Biópsia muscular With the study subject resting in the supine position, the skin is disinfected on the lateral side of the thigh around 15 cm above the knee, with chlorhexidine alcohol. Then 3-4 mL of local anaesthetic (lidocaine 20 mg/mL) is injected into the skin, subcutaneous tissue and in the upper part of the muscle with a very thin needle. When the anaesthetic effect has set in after a couple of minutes an insertion is made in ...Mostrar mais Biópsia de tecido adiposo With the study subject resting in the supine position, the skin is disinfected on one side of the abdomen around 5-10 cm lateral from the umbilicus to the knee, with chlorhexidine alcohol. Then 3-4 mL of local anaesthetic (lidocaine 20 mg/mL) is injected into the skin, subcutaneous tissue and in the upper part of the adipose tissue with a very thin needle. When the anaesthetic effect has set in after a couple of minu...Mostrar mais Glucagon Glucagon is prepared in doses of 10 µg, 25 µg, and 50 µg and intravenously injected with intervals of 2 hours. After each glucagon injection, blood samples will be drawn to measure plasma glucose, glucagon, lactate, free fatty acids, alanine, amino-acids, β-hydroxybutyrate, glycerol and insulin. Furthermore, cardiovascular measurements such as pulse and blood pressure are monitored as well. IPRO 2 Medtronic Minimed All potential subjects will receive a blinded continuous glucose sensor at Visit 1. At the following visits, the continuous glucose monitor (CGM) will be reviewed for hypoglycaemia episodes and replaced at the same time. At Visit 2 a final screening of the inclusion criteria will take place, which involves the CGM data of the first week. A blinded CGM will be installed a week before every visit. 7 Tesla (7T) Magnetic Resonance Imaging Subjects will undergo a hyperinsulinemic euglycaemic glucose clamp, as mentioned above, in the MRI scanning room. After 30 minutes of stable normoglycaemia, subjects are taken into the MRI scanner (Philips Achieva 7.0 T) where brain, liver, thigh and calf muscle are scanned. After every anatomically different area, the subjects must be taken out of the scanner, while scanning coils are replaced. All subjects are advi...Mostrar mais Indirect Calorimetry using Jaeger Oxycon Champion Resting metabolic rate will be estimated, after reaching stable plasma glucose level, via a hyperinsulinemic euglycaemic clamp, as mentioned above. This will be done by indirect calorimetry, using a ventilated hood system (Jaeger Oxycon Champion, software version 4.3, Jaeger, Mijnhardt). Subjects are instructed to lie down and rest for a period of 30 minutes. Subjects are also instructed not to move, talk or sleep un...Mostrar mais Core temperature and thermography using Thermovision SC645 Thermography (Thermovision SC645, FLIR Systems, Wilsonville, OR, USA) is used to determine cutaneous vascular perfusion. Data is analogue-digital converted and sampled at 100 Hz (Powerlab, ADInstruments, Colorado Springs, CO, USA). |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- Ability to provide written informed consent
- Male or female aged 18-70 years
- Must be able to speak and read Danish
- Type 1 diabetes patients or healthy individuals (control goup)
- A documented clinically relevant history of type 1 diabetes
- In insulin treatment regimen
- The subject must be willing and able to comply with trial protocol
- History of severe psychological condition
- History of severe heart disease
- History of epilepsy, former apoplexies and dementia
- History of muscle diseases
- History of liver disease
- History of malignancy unless a disease-free period exceeding 5 years
- Implants not compatible for MRI scans
- History of alcohol or drug abuse
- Pregnant or lactating woman
Nordsjaellands HospitalSem dados de contato.
2 Locais do estudo em 1 países
Steno Diabetes Center Copenhagen, Gentofte Municipality, 2820, Denmark
Nordsjaellands Hospital, Hillerød, 3400, Denmark