Type 2 Diabetes MellitusNCT01476384
Orthogonal Polarisation Study in Young, Elderly and Type 2 Diabetics
A study testing Glucose in people with Type 2 Diabetes Mellitus, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Glucose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2010to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%
Show all 10Show fewer
- Diagnosed impaired renal or liver function
- Obesity (BMI>30 kg/m2)
- Cardiac disease or cardiovascular problems in history
- Overt diabetic complications
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center+
Maastricht, Limburg, 6229ER
About this study
Official title: Postprandial Insulin Release and the Impact on Muscle Perfusion
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Glucose, Placebo
- Keywords
- Glucose, insulin, Glycocalyx, Muscle, Vascularisation, young, elderly
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseDietary supplement
Also called GLU
Glucose drink: 75 gram dextrose monohydrate, dissolved in 250 ml water
PlaceboDietary supplement
Also called PLA
250 ml water
| Study group | Role | What they receive |
|---|---|---|
| Glucose drink | Experimental | 75 gram glucose, dissolved in 250 ml water Receives: Dietary Supplement: Glucose |
| Placebo | Placebo comparator | 250 ml water Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after ingestion of the drink
Secondary outcomes (1)
Microvascular density
Determination of microvascular density in muscle tissue in young, elderly and type 2 diabetic patients.
Measured: 3 h after ingestion of glucose drink
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LJC van Loon, Professor, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476384
- Sponsor's protocol ID
- MEC 10-3-050
- Other IDs
- MET 10-3-050
- Status last verified
- Apr 2014
- First submitted
- 14 Nov 2011
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Groen BB, Hamer HM, Snijders T, van Kranenburg J, Frijns D, Vink H, van Loon LJ. Skeletal muscle capillary density and microvascular function are compromised with aging and type 2 diabetes. J Appl Physiol (1985). 2014 Apr 15;116(8):998-1005. doi: 10.1152/japplphysiol.00919.2013. Epub 2014 Feb 27.
PubMed 24577061
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Insulin Release and the Impact on Muscle Perfusion
- ClinicalTrials.gov ID
- NCT01476384
- Acronym / sponsor ID
- MEC 10-3-050
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Glucose, insulin, Glycocalyx, Muscle, Vascularisation, young, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose drink | Experimental | Dietary Supplement: Glucose75 gram glucose, dissolved in 250 ml water |
| Placebo | Placebo comparator | Dietary Supplement: Placebo250 ml water |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucoseAlso: GLUGlucose drink: 75 gram dextrose monohydrate, dissolved in 250 ml water | Dietary supplement | Glucose drink |
| PlaceboAlso: PLA250 ml water | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
Microvascular density
Time frame: 3 h after ingestion of glucose drink
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
- Derived from this study: PubMed 24577061Groen BB, Hamer HM, Snijders T, van Kranenburg J, Frijns D, Vink H, van Loon LJ. Skeletal muscle capillary density and microvascular function are compromised with aging and type 2 diabetes. J Appl Physiol (1985). 2014 Apr 15;116(8):998-1005. doi: 10.1152/japplphysiol.00919.2013. Epub 2014 Feb 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LJC van Loon, Professor principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose in people with Type 2 Diabetes Mellitus, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycocalyx permeability (time frame: 30 minutes after ingestion of the drink). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01476384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2014.