ClinicalTrials.gg
Status unknownNCT02708875Updated Apr 6, 2021

Microvascular Insulin Resistance and Mixed Meal Challenge

An interventional study of Mixed Meal Challenge and Glucose Challenge in Insulin Resistance, sponsored by Menzies Institute for Medical Research. Status unknown at 2 sites in Australia. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-06.

Sponsored by Menzies Institute for Medical Research · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Aug 2014, registered Feb 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Insulin Resistance

Browse trials for

Keywords

  • Microvascular
  • Insulin resistance
  • Mixed Meal
  • Glucose tolerance
03

In context

Insulin Resistance

2,025 studies on the registry are indexed under Insulin Resistance; 308 are open to participants now.

This study's planned enrollment of 45 is above the median of 40 across 1,587 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Menzies Institute for Medical Research is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherMixed Meal Challenge

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

  • OtherGlucose Challenge

    Glucose drink (50g glucose)

06

What researchers measure

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.

    Time frame: 1 hr

Secondary outcomes

  1. Changes in blood glucose levels

    Blood glucose levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.

    Time frame: 2 hr

  2. Changes in plasma insulin levels

    Plasma insulin levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.

    Time frame: 2hr

  3. Changes in the respiratory exchange ratio (RER)

    Changes in RER will be measured by metabolic cart during each challenge.

    Time frame: 1 hr

07

Study locations

2 sites
  • Menzies Institute for Medical Research
    Hobart, Tasmania 7000, Australia
  • Deakin University
    Burwood, Victoria 3125, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02708875
Lead sponsor
Menzies Institute for Medical Research
Collaborators
Deakin University
Responsible party
Michelle Keske (Senior Research Fellow, Menzies Institute for Medical Research) — Principal investigator
First posted
Mar 15, 2016
Start date
Aug 2014
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Apr 6, 2021

Study contacts

Michelle A Keske, PhD
principal investigator · Menzies Institute for Medical Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion