Viewing Study NCT06490900



Ignite Creation Date: 2024-07-17 @ 10:47 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06490900
Status: RECRUITING
Last Update Posted: 2024-07-08
First Post: 2024-06-29

Brief Title: Influence of Intermittent Hypoxia on Glycemic Control
Sponsor: University of Texas at Austin
Organization: University of Texas at Austin

Study Overview

Official Title: Influence of One Session of Intermittent Hypoxia on Glycemic Control
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of this research project is to determine the effect of intermittent hypoxia on glucose uptake in response to an oral glucose tolerance test in healthy individuals individuals with prediabetes and patients with type 2 diabetes
Detailed Description: For the past 100 years cardiovascular disease has been the leading cause of death in the United States An aging population increasing levels of obesity and the predominance of a sedentary lifestyle contribute to the growing incidence of type 2 diabetes one of the major modifiable risk factors for cardiovascular disease It is now predicted that 1 in 3 adults will develop diabetes by 2050 implying that a large percentage of the population will become at high risk for cardiovascular disease the most common cause of death in patients with type 2 diabetes While exercise reduces insulin resistance and the elevated glucose levels associated with type 2 diabetes only 28 of the adult population with diabetes meet physical activity recommendations Thus our overall objective is to identify an alternative non-pharmacological intervention that prevents the development of type 2 diabetes in individuals with prediabetes and treats the insulin resistance and hyperglycemia in patients already diagnosed with type 2 diabetes

The Nobel Prize in Physiology was recently awarded to scientists who established the basis for our understanding of how varying oxygen levels affect cellular metabolism which paved the way for promising new strategies to fight diseases Breathing low levels of oxygen or hypoxia stimulates glucose uptake in skeletal muscle via 5 adenosine monophosphate-activated protein kinase AMPK the same signaling pathway as muscle contraction which acts independently from the actions of insulin Thus patients with type 2 diabetes were exposed to either normoxia or 60 min of continuous hypoxia fraction of inspired oxygen of 015 arterial oxygen saturation of 92 immediately before performing a 4-hour intravenous glucose tolerance test Hypoxia lowered blood glucose levels and did not affect insulin concentrations therefore it was suggested that the improved glycemic control was caused by the activation of the AMPK pathway in combination with an improved insulin sensitivity Similarly a single exposure to intermittent hypoxia consisting of 6 min at a fraction of inspired oxygen of 013 alternated with 6 min of normoxia for 1 hour improved glycemic control in patients with type 2 diabetes Specifically there was a greater decrease in glucose levels measured immediately after intermittent hypoxia and the increase in glucose levels following a meal was attenuated following intermittent hypoxia when compared to a placebo condition A decrease in glucose levels was also observed following a single session of intermittent hypoxia consisting of brief desaturation and resaturation cycles to maintain an arterial oxygen saturation of 80 for approximately 70 min in overweight and obese individuals with normal baseline glucose levels

The specific aim of this research project is to identify whether exposure to intermittent hypoxia during an oral glucose tolerance test attenuates the increase in glucose levels in healthy individuals individuals with prediabetes and patients with type 2 diabetes It is hypothesized that exposure to intermittent hypoxia will attenuate the increase in glucose levels in response to an oral glucose tolerance test in healthy individuals individuals with prediabetes and patients with type 2 diabetes

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None