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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02708875




Registration number
NCT02708875
Ethics application status
Date submitted
17/02/2016
Date registered
15/03/2016

Titles & IDs
Public title
Microvascular Insulin Resistance and Mixed Meal Challenge
Scientific title
Microvascular Insulin Resistance and Mixed Meal Challenge
Secondary ID [1] 0 0
H14086
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin Resistance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Mixed Meal Challenge
Other interventions - Glucose Challenge

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.

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 interventions: Mixed Meal Challenge
Liquid mixed meal (300 calories - fat, carbohydrate, and protein).

Other interventions: Glucose Challenge
Glucose drink (50g glucose)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in muscle microvascular blood flow
Timepoint [1] 0 0
1 hr
Secondary outcome [1] 0 0
Changes in blood glucose levels
Timepoint [1] 0 0
2 hr
Secondary outcome [2] 0 0
Changes in plasma insulin levels
Timepoint [2] 0 0
2hr
Secondary outcome [3] 0 0
Changes in the respiratory exchange ratio (RER)
Timepoint [3] 0 0
1 hr

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment hospital [1] 0 0
Menzies Institute for Medical Research - Hobart
Recruitment hospital [2] 0 0
Deakin University - Burwood
Recruitment postcode(s) [1] 0 0
7000 - Hobart
Recruitment postcode(s) [2] 0 0
3125 - Burwood

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies Institute for Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Deakin University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michelle A Keske, PhD
Address 0 0
Menzies Institute for Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02708875