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Microvascular Insulin Resistance and Mixed Meal Challenge

Microvascular Insulin Resistance and Mixed Meal Challenge

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02708875
Enrollment
45
Registered
2016-03-15
Start date
2014-08-31
Completion date
2021-12-31
Last updated
2021-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

Microvascular, Insulin resistance, Mixed Meal, Glucose tolerance

Brief summary

Insulin resistance (or pre-diabetes) is diagnosed using the oral glucose tolerance test. However, high blood glucose levels during this test may adversely impact on microvascular function. Investigators will determine whether a liquid mixed meal challenge (from carbohydrate, protein and fat) is a more appropriate test for assessing microvascular-derived insulin resistance.

Detailed description

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.

Interventions

Liquid mixed meal (300 calories - fat, carbohydrate, and protein).

Glucose drink (50g glucose)

Sponsors

Deakin University
CollaboratorOTHER
Menzies Institute for Medical Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 18-70 years. * Normal to overweight (BMI 19-35 kg/m2). * Normotensive (Seated brachial blood pressure \<160/100 mmHg). * Considered healthy (HbA1c \<6.5 %) or have clinically diagnosed type 2 diabetes. * Either have a parent with T2D, or no family history of type 2 diabetes for two generations. * Have given signed informed consent to participate in the study

Exclusion criteria

* Age \<18 yrs or \>70 yrs * Morbidly obese with a BMI ≥36 kg/m2 * History of myocardial infarction or stroke * History of malignancy within past 5 years (except for non-melanoma skin cancers) * Current smoker * History of severe liver disease * History of drug or alcohol abuse * Elective major surgery during the course of the study * Pregnancy/lactation * Participation or intention to participate in another clinical research study during the study period.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in muscle microvascular blood flow1 hrMicrovascular responses will be measured by contrast enhanced ultrasound before and 1hr after each challenge.

Secondary

MeasureTime frameDescription
Changes in blood glucose levels2 hrBlood glucose levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.
Changes in plasma insulin levels2hrPlasma insulin levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.
Changes in the respiratory exchange ratio (RER)1 hrChanges in RER will be measured by metabolic cart during each challenge.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026