Microvascular Insulin Resistance and Mixed Meal Challenge

Insulin Resistance Clinical Trial

Official title:

Microvascular Insulin Resistance and Mixed Meal Challenge

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02708875
• Other study ID #: H14086
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: Menzies Institute for Medical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Other:
• Mixed Meal Challenge
Liquid mixed meal (300 calories - fat, carbohydrate, and protein).
• Glucose Challenge
Glucose drink (50g glucose)

Locations

Country	Name	City	State
Australia	Deakin University	Burwood	Victoria
Australia	Menzies Institute for Medical Research	Hobart	Tasmania

Sponsors (2)

Lead Sponsor	Collaborator
Menzies Institute for Medical Research	Deakin University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in muscle microvascular blood flow	Microvascular responses will be measured by contrast enhanced ultrasound before and 1hr after each challenge.	1 hr
Secondary	Changes in blood glucose levels	Blood glucose levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.	2 hr
Secondary	Changes in plasma insulin levels	Plasma insulin levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.	2hr
Secondary	Changes in the respiratory exchange ratio (RER)	Changes in RER will be measured by metabolic cart during each challenge.	1 hr