The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance.

Обзор

This study will investigating the effects of glucagon on renal blood flow in humans using MRI technology. Glucagon, a hormone produced by the pancreas, plays a key role in regulating blood sugar levels. It has been shown to affect renal function, including electrolyte balance and blood flow, especially in conditions like type 2 diabetes where abnormal glucagon levels are common. The study aims to understand how glucagon affects regional blood flow in the kidneys, specifically the cortex and medulla, and whether these effects are mediated by glucagon receptors. The study will be conducted on 10 healthy male participants aged 20-60 years. It involves three test days where participants will receive either glucagon, glucagon with a GLP-1 receptor antagonist, or placebo. Blood flow, glomerular filtration rate, and other renal functions will be measured using MRI. The study seeks to clarify whether glucagon's effects on the kidneys are linked to changes in regional blood flow and to determine if these effects are mediated solely by glucagon receptors.

Вмешательства

• Препарат Glucagon
  Glucagon infusion at 5 ng·kg-¹·min-¹ from 0-30 minutes and 10 ng·kg-¹·min-¹ from 30-60 minutes.
• Препарат Glucagon+Exendin9-39
  Glucagon infusion at 5 ng·kg-¹·min-¹ from 0-30 minutes and 10 ng·kg-¹·min-¹ from 30-60 minutes, plus a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-¹·min-¹), given intravenously from -30 to 60 minutes
• Препарат Sodium chloride
  Placebo (0.9% NaCl).

Первичные конечные точки

• Blood perfusion of the kidney [Срок оценки: 7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).]

Вторичные конечные точки (2)

• Blood flow of the renal arteries [Срок оценки: 7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).]
• blood oxygen saturation of the kidneys [Срок оценки: 7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).]

Критерии участия

Критерии включения

• Normal health confirmed through; Interview and Medical examination
• Normal values with respect to blood concentrations of fasting plasma glucose, fasting plasma total cholesterol, fasting triglycerides, HDL, LDL, creatinine, liver function tests, and electrolytes
• Informed consent

Критерии исключения

• Immunosuppressive treatment in the previous 12 months
• Alcohol abuse
• Medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (DPP-4) inhibitors, or GLP-1 receptor agonists, which, in the opinion of the principal investigator, may interfere with glucose metabolism
• Use of lithium
• Medical treatment that affects insulin secretion or the renin-angiotensin-aldosterone system
• Liver disease (ALT > 2x normal value)
• Renal impairment (serum creatinine > 130 µM and/or albuminuria)
• Individuals with severe claustrophobia
• Individuals with MR-incompatible foreign bodies
• Individuals with hypertension

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

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06872060 · H-24012271

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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