Insulin ResistanceNCT02708875
Microvascular Insulin Resistance and Mixed Meal Challenge
A study testing Mixed Meal Challenge and Glucose Challenge in people with Insulin Resistance, run by Menzies Institute for Medical Research at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Mixed Meal Challenge and Glucose Challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesAustralia
- Study dates
- Aug 2014to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Deakin University
Burwood, Victoria, 3125
Menzies Institute for Medical Research
Hobart, Tasmania, 7000
About this study
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.
- Conditions
- Insulin Resistance
- Being tested
- Mixed Meal Challenge, Glucose Challenge
- Keywords
- Microvascular, Insulin resistance, Mixed Meal, Glucose tolerance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Meal ChallengeOther
Liquid mixed meal (300 calories - fat, carbohydrate, and protein).
Glucose ChallengeOther
Glucose drink (50g glucose)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Glucose Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in muscle microvascular blood flow
Microvascular responses will be measured by contrast enhanced ultrasound before and 1hr after each challenge.
Measured: 1 hr
Secondary outcomes (3)
Changes in blood glucose levels
Blood glucose levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.
Measured: 2 hr
Changes in plasma insulin levels
Plasma insulin levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.
Measured: 2hr
Changes in the respiratory exchange ratio (RER)
Changes in RER will be measured by metabolic cart during each challenge.
Measured: 1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startAug 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menzies Institute for Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Deakin University
- Responsible party
- Principal investigator, Michelle Keske, Menzies Institute for Medical Research
- Investigators
- Michelle A Keske, PhD, Principal investigator, Menzies Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708875
- Sponsor's protocol ID
- H14086
- Status last verified
- Apr 2021
- First submitted
- 17 Feb 2016
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Insulin Resistance and Mixed Meal Challenge
- ClinicalTrials.gov ID
- NCT02708875
- Acronym / sponsor ID
- H14086
- Conditions
- Insulin Resistance
- Keywords
- Microvascular, Insulin resistance, Mixed Meal, Glucose tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Menzies Institute for Medical ResearchUniversity, hospital or other
- Collaborators
- Deakin University
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mixed Meal Challenge | Experimental | Other: Mixed Meal ChallengeParticipants 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. |
| Glucose Challenge | Active comparator | Other: Glucose ChallengeParticipants will consume a glucose challenge (50g glucose) for monitoring changes in glucose metabolism, plasma insulin and microvascular responses in skeletal muscle over 2 hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed Meal ChallengeLiquid mixed meal (300 calories - fat, carbohydrate, and protein). | Other | Mixed Meal Challenge |
| Glucose ChallengeGlucose drink (50g glucose) | Other | Glucose Challenge |
Primary outcome
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.
3 secondary outcomes
Changes in blood glucose levels
Time frame: 2 hr
Changes in plasma insulin levels
Time frame: 2hr
Changes in the respiratory exchange ratio (RER)
Time frame: 1 hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle A Keske, PhD principal investigator
Menzies Institute for Medical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Meal Challenge and Glucose Challenge in people with Insulin Resistance, run by Menzies Institute for Medical Research at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in muscle microvascular blood flow (time frame: 1 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.