Orthogonal Polarisation Study in Young, Elderly and Type 2 Diabetics
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|ClinicalTrials.gov Identifier: NCT01476384|
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : April 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Dietary Supplement: Glucose Dietary Supplement: Placebo||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Postprandial Insulin Release and the Impact on Muscle Perfusion|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||March 2014|
Experimental: Glucose drink
75 gram glucose, dissolved in 250 ml water
Dietary Supplement: Glucose
Glucose drink: 75 gram dextrose monohydrate, dissolved in 250 ml water
Other Name: GLU
Placebo Comparator: Placebo
250 ml water
Dietary Supplement: Placebo
250 ml water
Other Name: PLA
- 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.
- 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.
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): NCT01476384
|Maastricht University Medical Center+|
|Maastricht, Limburg, Netherlands, 6229ER|
|Principal Investigator:||LJC van Loon, Professor||Maastricht University|