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Orthogonal Polarisation Study in Young, Elderly and Type 2 Diabetics

This study is currently recruiting participants.
Verified May 2013 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01476384
First received: November 14, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

Aging is accompanied by a progressive loss of skeletal muscle mass and strength, leading to the loss of functional capacity and an increased risk of developing chronic metabolic disease. One of these metabolic diseases interacting with muscle mass is Diabetes Mellitus type 2. Diabetes Mellitus type 2 is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. It has become clear that amongst its many actions, insulin is also a vasoactive hormone. Its effect to cause endothelial-nitric oxide dependent vasodilation is physiologic and dose dependent. Recent data suggest that insulin's metabolic and vascular actions are closely linked. This also means that an increase in microvascular perfusion following food intake is more resistant to postprandial insulin release. This physiological process is brought into prominence with increasing age, and even more in type 2 diabetics, and contributes to diminishing glycaemic control. In the present study the investigators will investigate the impact of postprandial insulin release on microvascular recruitment in the oral cavity.


Condition Intervention
Type 2 Diabetes Mellitus
 Dietary Supplement: Glucose
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Postprandial Insulin Release and the Impact on Muscle Perfusion

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Glycocalyx permeability [ Time Frame: 30 minutes after ingestion of the drink ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Microvascular density [ Time Frame: 3 h after ingestion of glucose drink ] [ Designated as safety issue: No ]
    Determination of microvascular density in muscle tissue in young, elderly and type 2 diabetic patients.


Estimated Enrollment: 45
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476384

Contacts
Contact: LJC van Loon, Professor 0031433881397 L.vanLoon@maastrichtuniversity.nl
Contact: BBL Groen, MD 0031433881390 Bart.Groen@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Medical Center+ Recruiting
Maastricht, Limburg, Netherlands, 6229ER
Contact: LJC van Loon, Professor     0031433881397     L.vanLoon@maastrichtuniversity.nl    
Contact: BBL Groen, MD     0031433881390     Bart.Groen@maastrichtuniversity.nl    
Principal Investigator: LJC van Loon, Professor            
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: LJC van Loon, Professor Maastricht University
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01476384     History of Changes
Other Study ID Numbers: MEC 10-3-050, MET 10-3-050
Study First Received: November 14, 2011
Last Updated: May 13, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
Glucose
insulin
Glycocalyx
Muscle
 Vascularisation
young
elderly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013