- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01476384
Orthogonal Polarisation Study in Young, Elderly and Type 2 Diabetics
Postprandial Insulin Release and the Impact on Muscle Perfusion
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To fulfil the increasing demand for real-time evaluation of micro vascular flow in muscle tissue, new techniques have been evaluated. The conventional systemic hemodynamic and oxygenation parameters are neither specific nor sensitive enough to detect regional perfusion. A more complete evaluation of tissue oxygenation can be achieved by adding noninvasive assessment of perfusion in peripheral tissues to global parameters. Noninvasive monitoring of peripheral perfusion could be a complementary approach that allows very early application throughout the hospital and interventional research. Orthogonal polarization spectral (OPS) is a non invasive technique that uses reflected light to produce real-time images of the microcirculation. The technology has been incorporated into a small hand-held videomicroscope which can be used in both research and clinical settings. OPS can assess tissue perfusion using the functional capillary density (FCD), i.e., the length of perfused capillaries per observation area (measured as cm/cm2).
FCD is a very sensitive parameter for determining the status of nutritive perfusion to the tissue. So far, one of the most easily accessible sites in humans for peripheral perfusion monitoring is the mouth. OPS produces excellent images of the sublingual microcirculation by placing the probe under the tongue. Movement artifacts, semiquantitative measure of perfusion, the presence of various secretions such as saliva and blood, observer-related bias, and malfunction of the apparatus are some of the limitations of the technique.
In the present study we will investigate the impact of postprandial insulin release on microvascular recruitment in the oral cavity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ER
- Maastricht University Medical Center+
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male
- Aged between 20-30 or 65-80 years
- BMI < 30 kg/m2
- Non insulin-dependent Diabetes mellitus type 2 patients. Use of oral anti-diabetic agents (TZD's, Metformin and/or a sulfonylurea derivative) is allowed.
Exclusion Criteria:
- Positive history for hypertension
- Smoking
- Hypertension (according to WHO criteria)18
- Use of medication, except for oral blood glucose lowering medication
- All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis).
- HbA1c > 10.0%
- Diagnosed impaired renal or liver function
- Obesity (BMI>30 kg/m2)
- Cardiac disease or cardiovascular problems in history
- Overt diabetic complications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Glucose drink
75 gram glucose, dissolved in 250 ml water
|
Glucose drink: 75 gram dextrose monohydrate, dissolved in 250 ml water
Other Names:
|
PLACEBO_COMPARATOR: Placebo
250 ml water
|
250 ml water
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycocalyx permeability
Time Frame: 30 minutes after ingestion of the drink
|
Changes in glycocalyx permeability in young, elderly and type 2 diabetics after ingestion of a glucose or water (placebo) drink.
The glycocalyx will be measured during 2 h after ingestion of the drink.
|
30 minutes after ingestion of the drink
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microvascular density
Time Frame: 3 h after ingestion of glucose drink
|
Determination of microvascular density in muscle tissue in young, elderly and type 2 diabetic patients.
|
3 h after ingestion of glucose drink
|
Collaborators and Investigators
Investigators
- Principal Investigator: LJC van Loon, Professor, Maastricht University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 10-3-050
- MET 10-3-050 (REGISTRY: MET 10-3-050)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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