Microvascular Insulin Resistance and Mixed Meal Challenge

NCT02708875 | Unknown

• 1 other identifier: H14086
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Insulin Resistance

Keywords

Microvascular; Insulin resistance; Mixed Meal; Glucose tolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in blood glucose levels

  2 hr

• Changes in plasma insulin levels

  2hr

• Changes in the respiratory exchange ratio (RER)

  1 hr

Study Arms (2)

Mixed Meal Challenge

EXPERIMENTAL

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

Glucose Challenge

ACTIVE COMPARATOR

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

Interventions

Mixed Meal Challenge OTHER

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

Mixed Meal Challenge

Glucose Challenge OTHER

Glucose drink (50g glucose)

Glucose Challenge

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menzies Institute for Medical Research: lead
• Deakin University: collaborator

Study Sites (2)

Menzies Institute for Medical Research

Hobart, Tasmania, 7000, Australia

Location

Deakin University

Burwood, Victoria, 3125, Australia

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michelle A Keske, PhD

  Menzies Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 15, 2016
• Study Start: August 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)