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Microvascular Insulin Resistance and Mixed Meal Challenge

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ClinicalTrials.gov Identifier: NCT02708875
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Michelle Keske, Menzies Institute for Medical Research

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Other: Mixed Meal Challenge Other: Glucose Challenge Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Microvascular Insulin Resistance and Mixed Meal Challenge
Study Start Date : December 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Liquid mixed meal (300 calories - fat, carbohydrate, and protein).

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
Glucose drink (50g glucose)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes in blood glucose levels [ Time Frame: 2 hr ]
    Blood glucose levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.

  2. Changes in plasma insulin levels [ Time Frame: 2hr ]
    Plasma insulin levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.

  3. Changes in the respiratory exchange ratio (RER) [ Time Frame: 1 hr ]
    Changes in RER will be measured by metabolic cart during each challenge.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18-60 years.
  • Normal to overweight (BMI 19-35 kg/m2).
  • Normotensive (Seated brachial blood pressure <140/90 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 >60 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708875


Contacts
Contact: Michelle A Keske, PhD +61362262669 Michelle.Keske@utas.edu.au

Locations
Australia, Tasmania
Menzies Institute for Medical Research Recruiting
Hobart, Tasmania, Australia, 7000
Contact: Michelle A Keske, PhD    +61362262669    Michelle.Keske@utas.edu.au   
Contact: Michelle Keske    +61362262669      
Sponsors and Collaborators
Menzies Institute for Medical Research
Investigators
Principal Investigator: Michelle A Keske, PhD Menzies Institute for Medical Research

Responsible Party: Michelle Keske, Senior Research Fellow, Menzies Institute for Medical Research
ClinicalTrials.gov Identifier: NCT02708875     History of Changes
Other Study ID Numbers: H14086
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Michelle Keske, Menzies Institute for Medical Research:
Microvascular
Insulin resistance
Mixed Meal
Glucose tolerance

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs