Forearm Immobilization in T2D

Официальное название

The Impact of Short-term Forearm Immobilization on Forearm Muscle Glucose and Amino Acid Metabolism of Volunteers With or Without Type 2 Diabetes

Обзор

The aim of the present study is to assess the impact of short-term forearm immobilization on forearm muscle glucose uptake and amino acid net balance and kinetics in individuals with T2D compared with a control group with normoglycaemia.

Подробное описание

Participants with and without T2D will undergo 2 days of forearm immobilization as a model of local physical inactivity. Before, throughout, and after immobilization arteriovenous forearm balance measurements will be combined with a stable isotope tracer infusion to measure muscle glucose uptake and amino acid balance, uptake, and efflux.

Вмешательства

• Поведенческое Forearm immobilization
  Two days of forearm immobilization

Первичные конечные точки

• Change in forearm muscle glucose uptake [Срок оценки: From 0 to 48 hours]

Вторичные конечные точки (5)

• Temporal change in forearm glucose uptake [Срок оценки: Prior to and for 3.5 hours following every meal consumption during the 48 hours forearm immobilization period]
• Change in forearm muscle amino acid kinetics [Срок оценки: Baseline and at regular intervals for 3.5 hours following the first and last meal consumption during the test period (0 to 48 hours)]
• Change in forearm muscle amino acid kinetics [Срок оценки: Baseline and at regular intervals for 3.5 hours following the first and last meal consumption during the test period (0 to 48 hours)]
• Change in forearm muscle amino acid kinetics [Срок оценки: Baseline and at regular intervals for 3.5 hours following the first and last meal consumption during the test period (0 to 48 hours)]
• Change in whole-body substrate oxidation [Срок оценки: Measurements will be performed at baseline, and at postprandial intervals (at 1 hour, 2 hours, 3 hours) during a 0 to 48-hour test period.]

Критерии участия

Критерии включения

• Males and females with or without diagnosed type 2 diabetes
• Use lifestyle changes, metformin, gliclazide, or a combination thereof as oral glucose-lowering treatments for T2D
• Aged 18-80 years at the time of signing informed consent
• 18.5 ≥ BMI ≤ 35 kg·m2

Критерии исключения

• Type 1 or a genetic form of diabetes
• Any diagnosed cardiovascular (heart) disease or high blood pressure (≥160 mmHg systolic and/or ≥100 mmHg diastolic)
• Chronic use of any prescribed or over-the-counter pharmaceuticals (excluding oral contraceptives and contraceptive devices) that interact with muscle substrate metabolism (e.g. selective serotonin reuptake inhibitors)
• Consumption of a low-carbohydrate diet
• Smoking or chewing tobacco
• Known anaemia
• Regular use of dietary protein and/or amino acid supplements (>3 times per week)
• Currently involved in a structured progressive resistance training program (>3 times per week)
• A personal or family history of thrombosis (clots)
• Any previous motor disorders or inborn errors in muscle and/or lipid metabolism
• History of kidney disease
• History of liver disease
• Pregnant or breastfeeding
• History of any drug or alcohol abuse in the past two years
• Claustrophobia
• Unable to give consent

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Нидерланды · 1 центр

• Wageningen University and Research — Wageningen

Идентификаторы

NCT: NCT06750497 · NL87404.028.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗