Microvascular Insulin Resistance and Mixed Meal Challenge
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|ClinicalTrials.gov Identifier: NCT02708875|
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance||Other: Mixed Meal Challenge Other: Glucose Challenge||Not Applicable|
After consuming a meal, 80% of glucose is disposed in skeletal muscle. Our research group has demonstrated that microvascular blood flow in skeletal muscle plays an integral role in this process. Physiological doses of insulin stimulate microvascular blood flow, and that this increase is associated with enhanced glucose uptake by muscle. This microvascular action of insulin is lost during insulin resistance and type 2 diabetes.
The oral glucose tolerance test (GTT) is the gold standard for assessing insulin resistance and pre-diabetes and is used world-wide. However high blood glucose levels following a glucose load may adversely impact on microvascular function. The aim of this project is to determine whether a mixed meal challenge (liquid drink consisting of carbohydrate, fat and protein) is a better test for assessing microvascular-derived insulin resistance.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Microvascular Insulin Resistance and Mixed Meal Challenge|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: Mixed Meal Challenge
Participants will consume a liquid mixed meal (300 calories - fat, carbohydrate, and protein) for monitoring changes in glucose metabolism, plasma insulin and microvascular responses in skeletal muscle over 2 hours.
Other: Mixed Meal Challenge
Liquid mixed meal (300 calories - fat, carbohydrate, and protein).
Active Comparator: Glucose Challenge
Participants will consume a glucose challenge (50g glucose) for monitoring changes in glucose metabolism, plasma insulin and microvascular responses in skeletal muscle over 2 hours.
Other: Glucose Challenge
Glucose drink (50g glucose)
- Change from baseline in muscle microvascular blood flow [ Time Frame: 1 hr ]Microvascular responses will be measured by contrast enhanced ultrasound before and 1hr after each challenge.
- Changes in blood glucose levels [ Time Frame: 2 hr ]Blood glucose levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.
- Changes in plasma insulin levels [ Time Frame: 2hr ]Plasma insulin levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.
- Changes in the respiratory exchange ratio (RER) [ Time Frame: 1 hr ]Changes in RER will be measured by metabolic cart during each challenge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708875
|Contact: Michelle A Keske, PhD||+61362262669||Michelle.Keske@utas.edu.au|
|Menzies Institute for Medical Research||Recruiting|
|Hobart, Tasmania, Australia, 7000|
|Contact: Michelle A Keske, PhD +61362262669 Michelle.Keske@utas.edu.au|
|Contact: Michelle Keske +61362262669|
|Principal Investigator:||Michelle A Keske, PhD||Menzies Institute for Medical Research|