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Microvascular Insulin Resistance and Mixed Meal Challenge

Primary Purpose

Insulin Resistance

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Mixed Meal Challenge
Glucose Challenge
Sponsored by
Menzies Institute for Medical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Insulin Resistance focused on measuring Microvascular, Insulin resistance, Mixed Meal, Glucose tolerance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Menzies Institute for Medical Research
  • Deakin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mixed Meal Challenge

Glucose Challenge

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in muscle microvascular blood flow
Microvascular responses will be measured by contrast enhanced ultrasound before and 1hr after each challenge.

Secondary Outcome Measures

Changes in blood glucose levels
Blood glucose levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.
Changes in plasma insulin levels
Plasma insulin levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.
Changes in the respiratory exchange ratio (RER)
Changes in RER will be measured by metabolic cart during each challenge.

Full Information

First Posted
February 17, 2016
Last Updated
April 4, 2021
Sponsor
Menzies Institute for Medical Research
Collaborators
Deakin University
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1. Study Identification

Unique Protocol Identification Number
NCT02708875
Brief Title
Microvascular Insulin Resistance and Mixed Meal Challenge
Official Title
Microvascular Insulin Resistance and Mixed Meal Challenge
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menzies Institute for Medical Research
Collaborators
Deakin University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Microvascular, Insulin resistance, Mixed Meal, Glucose tolerance

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mixed Meal Challenge
Arm Type
Experimental
Arm Description
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.
Arm Title
Glucose Challenge
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mixed Meal Challenge
Intervention Description
Liquid mixed meal (300 calories - fat, carbohydrate, and protein).
Intervention Type
Other
Intervention Name(s)
Glucose Challenge
Intervention Description
Glucose drink (50g glucose)
Primary Outcome Measure Information:
Title
Change from baseline in muscle microvascular blood flow
Description
Microvascular responses will be measured by contrast enhanced ultrasound before and 1hr after each challenge.
Time Frame
1 hr
Secondary Outcome Measure Information:
Title
Changes in blood glucose levels
Description
Blood glucose levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.
Time Frame
2 hr
Title
Changes in plasma insulin levels
Description
Plasma insulin levels will be measured at 0, 15, 30, 60, 90 and 120 min following each challenge.
Time Frame
2hr
Title
Changes in the respiratory exchange ratio (RER)
Description
Changes in RER will be measured by metabolic cart during each challenge.
Time Frame
1 hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle A Keske, PhD
Organizational Affiliation
Menzies Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menzies Institute for Medical Research
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Deakin University
City
Burwood
State/Province
Victoria
ZIP/Postal Code
3125
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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Microvascular Insulin Resistance and Mixed Meal Challenge

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