Diabetes Mellitus, Type 2NCT01241370
Skin and Retina Microvascular Endothelial Function in Healthy, Insulin Resistant and Type 2 Diabetic Subjects
An observational study of Diabetes Mellitus, Type 2, run by ELAB-Logistics at 1 site in Germany.
Trial summary
The purpose of this study is to investigate microvascular endothelial function in the retina of lean, obese, and type 2 diabetic subjects and to compare microvascular endothelial function in the retina with several other established markers of endothelial and microvascular function. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Apr 2010
- Phase
- Observational
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: It is planned to recruit up to 60 obese male and female subjects, stratified according to the following, 20 non-diabetic subjects with HOMAs ≤ 2, BMI < 28 kg/m² 20 non-diabetic subjects with HOMAs > 2, BMI ≥ 28 kg/m² 20 type 2 diabetic patients
Who may be able to join
- Age: 30 to 70 years
- Have given informed consent to participate in this study in accordance with local regulations
- Are reliable and willing to make themselves available for the duration of the study and will abide by the study restrictions
Who cannot join
- Smoking within the last 6 months
- Pre-proliferative or proliferative diabetic retinopathy
- Have a history of drug or alcohol abuse within the last 5 years
- Pregnant or intend to become pregnant during the course of the study
- Have a condition (including known drug abuse, alcohol abuse, or psychiatric disorder) which, in the opinion of the investigator, precludes the patient from following and completing the protocol
- Epilepsy
Show all 9Show fewer
- Lack of compliance or another, similar reason, that, in the judge of the investigator, precludes satisfactory participation in the study.
- Treatment with nitrates, angiotensin converting enzyme (ACE)-inhibitors, or angiotensin (AT) II blockers
- Treatment with glitazones
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate microvascular endothelial function in the retina of lean, obese, and type 2 diabetic subjects and to compare microvascular endothelial function in the retina with several other established markers of endothelial and microvascular function.
Read the detailed description
Insulin resistance is an early feature in obese patients lasting from hyperinsulinaemia with normal glycaemic control to impaired glucose tolerance and clinically manifest type 2 diabetes. Insulin resistance is closely associated to endothelial dysfunction and many other cardiovascular risk markers summarised under the definition of the metabolic syndrome. During the recent years, insulin resistance and the development of endothelial dysfunction were recognized as important pathogenetic drivers in the development of atherosclerosis and major predictors in the development of micro and macrovascular complications like retinopathy, nephropathy, myocardial infarction or stroke.
Several different technologies have been developed for the measurement of endothelial function in distinct vascular compartments like the flow mediated vasodilatation in the brachial artery, or numerous laser Doppler based technologies for the measurement of endothelial dependent microvascular blood flow responses in the skin. Even retinal vascular morphology could be easily visualized by direct fundoscopy, the investigation of retinal endothelial function had been a diagnostical challenge for decades. During the recent years, laser doppler scanning of the retina has become a widely used technology for the measurement of microvascular blood flow in the retina. Recently a new stimulation technology for the investigation of endothelial function in the retina has been developed and validated. Application of flickering light to the retina increases retinal blood flow by the stimulation of endothelial nitric oxide (NO) release, and laser Doppler scanning of the retina before and after the flicker light application could be used for the investigation of microvascular endothelial function in the eye. For assessing the stage of retinopathy a retinal image of 45° (papilla-centered) will be performed using a digital non-mydriatic fundus camera (Kowa Nonmyd 5). The image will be evaluated in respect to diabetic and hypertensive retinopathy in a standardized method. Also the equivalent arteriolar and venous diameter of the retinal vessels will be measured and the arterio-venous ratio will be calculated.
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Retinal endothelia dysfunction, Type 2 diabetes mellitus, Insulin-resistance, micro-lightguide spectrophotometry, laserdopplerfluxmetry
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lean healthy subjects | Homeostasis Model Assessment score (HOMAs) ≤ 2, Body Mass Index (BMI) ≤ 28 kg/m2 | |
| Insulin-resistnat subjects | HOMAs > 2, BMI > 28 kg/m2 | |
| Type 2 diabetic patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of retinal microvascular endothelial function in obese insulin sensitive, insulin-resistant and type 2 diabetic subjects with retinal microvascular endothelial function in lean healthy control subjects.
Measurements were taken from the superficial retinal layer (300 µm) using a scanning laser doppler flowmetry at 720 nm (Heidelberg Retina Flowmeter, Heidelberg Engineering)
Measured: 2-28 days
Secondary outcomes (4)
Comparison of microvascular endothelial function in the skin in obese and type 2 diabetic subjects with microvascular endothelial function in lean healthy control subjects.
A simultaneous micro-lightguide spectrophotometry and laserdoppler-fluxmetry were used to measure the microvascular skin blood flow and postcapillary tissue oxygenation in a depth of 2 mm at the lower forearm (oxygen to see (O2C), Lea Medizintechnik, Giessen, Germany).
Measured: 2-28 days
Comparison of microvascular endothelial function in the retina with microvascular endothelial function in the skin in diabetic and in non-diabetic subjects.
Measured: 2-28 days
Comparison of morphologic changes in retinal vessels (atrio-venous-ratio, diameter) in diabetic and in non-diabetic subjects.
Measured: 2-28 days
Comparison of the Oral Glucose Tolerance Test (OGTT) in the different subject groups with skin and retinal endothelial function.
Measured: 2-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startMay 2009
- Primary completionNov 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- ELAB-Logistics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IKFE Institute for Clinical Research and Development, Johannes Gutenberg University Mainz, University of Erlangen-Nürnberg Medical School
- Investigators
- Thomas Forst, MD, Principal investigator, Ikfe GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241370
- Sponsor's protocol ID
- IKFE-RET-001
- Status last verified
- Nov 2010
- First submitted
- 10 Nov 2010
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin and Retina Microvascular Endothelial Function in Healthy, Insulin Resistant and Type 2 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT01241370
- Acronym / sponsor ID
- IKFE-RET-001
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Retinal endothelia dysfunction, Type 2 diabetes mellitus, Insulin-resistance, micro-lightguide spectrophotometry, laserdopplerfluxmetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- ELAB-LogisticsIndustry (pharma, biotech, devices)
- Collaborators
- IKFE Institute for Clinical Research and Development, Johannes Gutenberg University Mainz, University of Erlangen-Nürnberg Medical School
- Study start
- May 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Nov 2010 (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.
The purpose of this study is to investigate microvascular endothelial function in the retina of lean, obese, and type 2 diabetic subjects and to compare microvascular endothelial function in the retina with several other established markers of endothelial and microvascular function.
Detailed description
Insulin resistance is an early feature in obese patients lasting from hyperinsulinaemia with normal glycaemic control to impaired glucose tolerance and clinically manifest type 2 diabetes. Insulin resistance is closely associated to endothelial dysfunction and many other cardiovascular risk markers summarised under the definition of the metabolic syndrome. During the recent years, insulin resistance and the development of endothelial dysfunction were recognized as important pathogenetic drivers in the development of atherosclerosis and major predictors in the development of micro and macrovascular complications like retinopathy, nephropathy, myocardial infarction or stroke.
Several different technologies have been developed for the measurement of endothelial function in distinct vascular compartments like the flow mediated vasodilatation in the brachial artery, or numerous laser Doppler based technologies for the measurement of endothelial dependent microvascular blood flow responses in the skin. Even retinal vascular morphology could be easily visualized by direct fundoscopy, the investigation of retinal endothelial function had been a diagnostical challenge for decades. During the recent years, laser doppler scanning of the retina has become a widely used technology for the measurement of microvascular blood flow in the retina. Recently a new stimulation technology for the investigation of endothelial function in the retina has been developed and validated. Application of flickering light to the retina increases retinal blood flow by the stimulation of endothelial nitric oxide (NO) release, and laser Doppler scanning of the retina before and after the flicker light application could be used for the investigation of microvascular endothelial function in the eye. For assessing the stage of retinopathy a retinal image of 45° (papilla-centered) will be performed using a digital non-mydriatic fundus camera (Kowa Nonmyd 5). The image will be evaluated in respect to diabetic and hypertensive retinopathy in a standardized method. Also the equivalent arteriolar and venous diameter of the retinal vessels will be measured and the arterio-venous ratio will be calculated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lean healthy subjects | – | –Homeostasis Model Assessment score (HOMAs) ≤ 2, Body Mass Index (BMI) ≤ 28 kg/m2 |
| Insulin-resistnat subjects | – | –HOMAs > 2, BMI > 28 kg/m2 |
| Type 2 diabetic patients | – | – |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to recruit up to 60 obese male and female subjects, stratified according to the following, 20 non-diabetic subjects with HOMAs ≤ 2, BMI < 28 kg/m² 20 non-diabetic subjects with HOMAs > 2, BMI ≥ 28 kg/m² 20 type 2 diabetic patients
Key inclusion criteria (3 listed)
- Age: 30 to 70 years
- Have given informed consent to participate in this study in accordance with local regulations
- Are reliable and willing to make themselves available for the duration of the study and will abide by the study restrictions
Key exclusion criteria (9 listed)
- Smoking within the last 6 months
- Pre-proliferative or proliferative diabetic retinopathy
- Have a history of drug or alcohol abuse within the last 5 years
- Pregnant or intend to become pregnant during the course of the study
- Have a condition (including known drug abuse, alcohol abuse, or psychiatric disorder) which, in the opinion of the investigator, precludes the patient from following and completing the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of retinal microvascular endothelial function in obese insulin sensitive, insulin-resistant and type 2 diabetic subjects with retinal microvascular endothelial function in lean healthy control subjects.
Time frame: 2-28 days
Measurements were taken from the superficial retinal layer (300 µm) using a scanning laser doppler flowmetry at 720 nm (Heidelberg Retina Flowmeter, Heidelberg Engineering)
4 secondary outcomes
Comparison of microvascular endothelial function in the skin in obese and type 2 diabetic subjects with microvascular endothelial function in lean healthy control subjects.
Time frame: 2-28 days
Comparison of microvascular endothelial function in the retina with microvascular endothelial function in the skin in diabetic and in non-diabetic subjects.
Time frame: 2-28 days
Comparison of morphologic changes in retinal vessels (atrio-venous-ratio, diameter) in diabetic and in non-diabetic subjects.
Time frame: 2-28 days
Comparison of the Oral Glucose Tolerance Test (OGTT) in the different subject groups with skin and retinal endothelial function.
Time frame: 2-28 days
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 16 Nov 2010.
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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.
Thomas Forst, MD principal investigator
Ikfe GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by ELAB-Logistics at 1 site in Germany.
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 3 inclusion and 9 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 16 Nov 2010. 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 Germany. 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. 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?
Comparison of retinal microvascular endothelial function in obese insulin sensitive, insulin-resistant and type 2 diabetic subjects with retinal microvascular endothelial function in lean healthy control subjects. (time frame: 2-28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2010.