Orthogonal Polarisation Study in Young, Elderly and Type 2 Diabetics

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Postprandial Insulin Release and the Impact on Muscle Perfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476384
• Other study ID #: MEC 10-3-050
• Secondary ID: MET 10-3-050
• Status: Completed
• Phase: N/A
• First received: November 14, 2011
• Last updated: April 10, 2014
• Start date: October 2010
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Glucose
Glucose drink: 75 gram dextrose monohydrate, dissolved in 250 ml water
• Placebo
250 ml water

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycocalyx permeability	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	No
Secondary	Microvascular density	Determination of microvascular density in muscle tissue in young, elderly and type 2 diabetic patients.	3 h after ingestion of glucose drink	No