Меню
Идёт набор NCT07019519

POTS-FLOW: Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS

Без фазы С лечением Postural Orthostatic Tachycardia Syndrome (POTS) Healthy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Saline/Placebo, GIPR antagonist, GLP-1R antagonist, CCK agonist.
Кому может быть актуально
Состояния в реестре: Postural Orthostatic Tachycardia Syndrome (POTS), Healthy. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS

Обзор

This study will describe the interplay between the gut hormones GIP and CCK and their regulation of blood flow to the large vessels in patients with Postural Orthostatic Tachycardia Syndrome (POTS) and GIP, CCK and GLP-1 in healthy. This is addressed by hormone infusions during MR-scans of the abdomen and intake of oral glucose.

Подробное описание

Each participant will attend independent randomized experimental days with MR-scans during and intravenous infusions of hormones or placebo and ingestion of glucose or water. A continuous intravenous infusion of either GIP(3-30)NH2, CCK8- or saline for POTS-group or GIP(3-30)NH2, CCK-8, saline or exendin(9-39)NH2 in healthy is started while the participant lie in the scanner while scans, blood samples and questionnaires are repeated over the time course of 2 hours. At a specific timepoint the participants will ingest 75 g of glucose dissolved in 250 ml water.

Вмешательства

  • Другое Saline/Placebo
    NaCl(9mg/ml)
  • Другое GIPR antagonist
    GIP(3-30)NH2
  • Другое GLP-1R antagonist
    GLP-1(9-39)NH2
  • Другое CCK agonist
    CCK-8

Первичные конечные точки

  • Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR) [Срок оценки: Continuously for 80 minutes/during infusions]
Вторичные конечные точки (9)
  • Blood flow in portal vein [Срок оценки: Continuously for 80 minutes/during infusions]
  • Blood Flow in celiac trunk [Срок оценки: Continuously for 80 minutes/during infusions]
  • Blood Flow in the hepatic artery [Срок оценки: Continuously for 80 minutes/during infusions]
  • Blood samples for hormones [Срок оценки: Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)]
  • Gastric emptying/Blood sample of paracetamol [Срок оценки: Every 10-20 minutes before, during and after the infusions and MRI scans (120 minutes)]
  • Symptomscoring [Срок оценки: Continously before and during the infusions (120 minutes)]
  • Blood samples for genes [Срок оценки: One measurement at baseline visit]
  • Blood sample for glucose [Срок оценки: Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)]
  • Blood samples for autoantibodies [Срок оценки: One measurement at baseline visit]

Критерии участия

Inclusion Criteria POTS patients:

  • Previously diagnosed with POTS in tilt test or active stand-test (either newly diagnosed within last 3 months or in new tilt test/active stand test during screenings visit)
  • Reproducible orthostatic intolerance with raise in HR on >30 bpm when standing within 10 minutes of change of supine to standing in age >19 years or >40 bpm in age 18-19 years.
  • POTS symptoms/orthostatic intolerance
  • Age 18-50
  • Waist ratio <180 cm

Критерии исключения

  • Chronic illness
  • Metallic implants
  • Above 10 alcoholic drinks or week or substance abuse
  • Other types of sinus tachycardia or heart disease
  • Liverenzymes two times above normal values
  • Decreased kidney function eGFR <90 or elevated kreatinkinasis
  • Thyroid disease or TSH out of reference
  • Uncontrollable low or high blood pressure
  • Blood vessels that cannot be visualized on MR
  • Any disease that might influence the health of the participant during the study or participants that receives medicine that cannot be paused for 36 hours

Критерии включения

  • Age 18-50
  • Waist ratio <180 cm
  • Matched a POTS patient in age, sex and BMI

Критерии исключения

  • Chronic illness
  • Metallic implants
  • Above 10 alcoholic drinks or week or substance abuse
  • POTS; other types of sinus tachycardia or heart disease
  • Liverenzymes two times above normal values
  • Decreased kidney function eGFR <90 or elevated kreatinkinasis
  • Thyroid disease or TSH out of reference
  • Uncontrollable low or high blood pressure, Orthostatic hypotension
  • Blood vessels that cannot be visualized on MR
  • Any disease that might influence the health of the participant during the study or participants that receives medicine that cannot be paused for 36 hours

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Дания · 1 центр
  • Rigshospitalet — Copenhagen

Публикации

  • Someya N, Endo MY, Fukuba Y, Hayashi N. Blood flow responses in celiac and superior mesenteric arteries in the initial phase of digestion. Am J Physiol Regul Integr Comp Physiol. 2008 Jun;294(6):R1790-6. doi: 10.1152/ajpregu.00553.2007. Epub 2008 Apr 2. PMID 18385466
  • Parker DR, Carlisle K, Cowan FJ, Corrall RJ, Read AE. Postprandial mesenteric blood flow in humans: relationship to endogenous gastrointestinal hormone secretion and energy content of food. Eur J Gastroenterol Hepatol. 1995 May;7(5):435-40. PMID 7614106
  • Randall EB, Billeschou A, Brinth LS, Mehlsen J, Olufsen MS. A model-based analysis of autonomic nervous function in response to the Valsalva maneuver. J Appl Physiol (1985). 2019 Nov 1;127(5):1386-1402. doi: 10.1152/japplphysiol.00015.2019. Epub 2019 Aug 1. PMID 31369335
  • Mehr SE, Barbul A, Shibao CA. Gastrointestinal symptoms in postural tachycardia syndrome: a systematic review. Clin Auton Res. 2018 Aug;28(4):411-421. doi: 10.1007/s10286-018-0519-x. Epub 2018 Mar 16. PMID 29549458
  • Breier NC, Paranjape SY, Scudder S, Mehr SE, Diedrich A, Flynn CR, Okamoto LE, Hartmann B, Gasbjerg LS, Shibao CA. Worsening Postural Tachycardia Syndrome Is Associated With Increased Glucose-Dependent Insulinotropic Polypeptide Secretion. Hypertension. 2022 May;79(5):e89-e99. doi: 10.1161/HYPERTENSIONAHA.121.17852. Epub 2022 Mar 2. PMID 35232225
  • Koffert J, Honka H, Teuho J, Kauhanen S, Hurme S, Parkkola R, Oikonen V, Mari A, Lindqvist A, Wierup N, Groop L, Nuutila P. Effects of meal and incretins in the regulation of splanchnic blood flow. Endocr Connect. 2017 Apr;6(3):179-187. doi: 10.1530/EC-17-0015. Epub 2017 Mar 3. PMID 28258126
  • Asmar M, Asmar A, Simonsen L, Gasbjerg LS, Sparre-Ulrich AH, Rosenkilde MM, Hartmann B, Dela F, Holst JJ, Bulow J. The Gluco- and Liporegulatory and Vasodilatory Effects of Glucose-Dependent Insulinotropic Polypeptide (GIP) Are Abolished by an Antagonist of the Human GIP Receptor. Diabetes. 2017 Sep;66(9):2363-2371. doi: 10.2337/db17-0480. Epub 2017 Jun 30. PMID 28667118
  • Asmar M, Simonsen L, Madsbad S, Stallknecht B, Holst JJ, Bulow J. Glucose-dependent insulinotropic polypeptide may enhance fatty acid re-esterification in subcutaneous abdominal adipose tissue in lean humans. Diabetes. 2010 Sep;59(9):2160-3. doi: 10.2337/db10-0098. Epub 2010 Jun 14. PMID 20547981

Идентификаторы

NCT: NCT07019519 · H-24030176

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗