Type 2 Diabetes MellitusNCT01456026
Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes
A study testing Glycated beta-lactoglobulins. and Non-glycated beta-lactoglobulins in people with Type 2 Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
Trial summary
Recent evidence supports detrimental effects of advanced glycation endproducts (AGE) on vascular function (VF). Though, the effect of AGE-modified proteins alone on vascular function remained unknown. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Glycated beta-lactoglobulins. and Non-glycated beta-lactoglobulins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to May 2010
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
Who cannot join
- Other types of diabetes
- Major cardiovascular complications within 6 months prior to screening
- Major diabetes complications
- Failure to give informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heart and Diabetes Center North-Rhine Westfalia
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
Official title: Acute Effects of Food Advanced Glycation Endproducts on Macrovascular Function in Subjects With Type 2 Diabetes Mellitus
Recent evidence supports detrimental effects of advanced glycation endproducts (AGE) on vascular function (VF). Though, the effect of AGE-modified proteins alone on vascular function remained unknown. Therefore, the aim of our study is to investigate the effects of heat-treated, glycated beta-lactoglobulins (BLG) on vascular function in subjects with type 2 diabetes mellitus (T2DM) and to compare it to non-glycated, heat-treated BLG.
Read the detailed description
In a double-blind, controlled, randomized, cross-over manner, 19 subjects with T2DM will receive on 2 different days beverages containing either glycated, heat-treated BLG or non-glycated, heat-treated BLG.
Macrovascular (brachial ultrasound of flow mediated dilatation -FMD) and microvascular function (laser-doppler measurements of reactive hyperemia at the hand) at baseline (T0), as well as 90 (T90) and 180 (T180) minutes after each beverage will be measured.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Glycated beta-lactoglobulins., Non-glycated beta-lactoglobulins
- Keywords
- Diabetes, Advanced glycation endproducts, Endothelium
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycated beta-lactoglobulins.Dietary supplement
oral, 20 g, single administration
Non-glycated beta-lactoglobulinsDietary supplement
20 g, oral, single administration,
| Study group | Role | What they receive |
|---|---|---|
| Glycated beta-lactoglobulins | Experimental | In this randomized, double blind,cross-over study, half of the subjects will receive on one day a beverage with a high AGE content and will be switched after a wash-out of min. 7 days to receive a low-AGE beverage (comparator). The other half will receive the beverages in inverse sequence. Receives: Dietary Supplement: Glycated beta-lactoglobulins. |
| Non-glycated beta-lactoglobulins | Active comparator | In this randomized, double blind,cross-over study, half of the subjects will receive on one day a beverage with a high AGE content and will be switched after a wash-out of min. 7 days to receive a low-AGE beverage (comparator). The other half will receive the beverages in inverse sequence. Receives: Dietary Supplement: Non-glycated beta-lactoglobulins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Change from Baseline in Flow Mediated Dilatation
Macrovascular (brachial ultrasound of flow mediated dilatation -FMD) will be measured at baseline (T0), as well as 90 (T90) and 180 (T180) minutes after each beverage. The hypothesis of our study is that an AGE-rich beverage acutely impairs FMD more than a beverage with a low AGE content.
Measured: Baseline, 90 and 180 min after oral intake of food AGE
Secondary outcomes (1)
Postprandial Change from Baseline in Microcirculation (Laser-Doppler measurements of reactive hyperemia at the hand)
Microvascular function will be measured at baseline (T0), as well as 90 (T90) and 180 (T180) minutes after each beverage. The hypothesis of our study is that an AGE-rich beverage acutely impairs microvascular function more than a beverage with a low AGE content.
Measured: Baseline, 90 and 180 min. following food AGE intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionMay 2010
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Heart and Diabetes Center North-Rhine Westfalia, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Alin O Stirban, M.D., Principal investigator, Profil Institute for Metabolic Research GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456026
- Sponsor's protocol ID
- Exogene-AGE
- Status last verified
- Oct 2011
- First submitted
- 14 Oct 2011
- Last updated
- 20 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Stirban A, Kotsi P, Franke K, Strijowski U, Cai W, Gotting C, Tschoepe D. Acute macrovascular dysfunction in patients with type 2 diabetes induced by ingestion of advanced glycated beta-lactoglobulins. Diabetes Care. 2013 May;36(5):1278-82. doi: 10.2337/dc12-1489. Epub 2012 Dec 13.
PubMed 23238657
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Food Advanced Glycation Endproducts on Macrovascular Function in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01456026
- Acronym / sponsor ID
- Exogene-AGE
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Advanced glycation endproducts, Endothelium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Heart and Diabetes Center North-Rhine Westfalia, Icahn School of Medicine at Mount Sinai
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 20 Oct 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.
Recent evidence supports detrimental effects of advanced glycation endproducts (AGE) on vascular function (VF). Though, the effect of AGE-modified proteins alone on vascular function remained unknown. Therefore, the aim of our study is to investigate the effects of heat-treated, glycated beta-lactoglobulins (BLG) on vascular function in subjects with type 2 diabetes mellitus (T2DM) and to compare it to non-glycated, heat-treated BLG.
Detailed description
In a double-blind, controlled, randomized, cross-over manner, 19 subjects with T2DM will receive on 2 different days beverages containing either glycated, heat-treated BLG or non-glycated, heat-treated BLG.
Macrovascular (brachial ultrasound of flow mediated dilatation -FMD) and microvascular function (laser-doppler measurements of reactive hyperemia at the hand) at baseline (T0), as well as 90 (T90) and 180 (T180) minutes after each beverage will be measured.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycated beta-lactoglobulins | Experimental | Dietary Supplement: Glycated beta-lactoglobulins.In this randomized, double blind,cross-over study, half of the subjects will receive on one day a beverage with a high AGE content and will be switched after a wash-out of min. 7 days to receive a low-AGE beverage (comparator). The other half will receive the beverages in inverse sequence. |
| Non-glycated beta-lactoglobulins | Active comparator | Dietary Supplement: Non-glycated beta-lactoglobulinsIn this randomized, double blind,cross-over study, half of the subjects will receive on one day a beverage with a high AGE content and will be switched after a wash-out of min. 7 days to receive a low-AGE beverage (comparator). The other half will receive the beverages in inverse sequence. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes mellitus
Key exclusion criteria (4 listed)
- Other types of diabetes
- Major cardiovascular complications within 6 months prior to screening
- Major diabetes complications
- Failure to give informed consent
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 |
|---|---|---|
| Glycated beta-lactoglobulins.oral, 20 g, single administration | Dietary supplement | Glycated beta-lactoglobulins |
| Non-glycated beta-lactoglobulins20 g, oral, single administration, | Dietary supplement | Non-glycated beta-lactoglobulins |
Primary outcome
Postprandial Change from Baseline in Flow Mediated Dilatation
Time frame: Baseline, 90 and 180 min after oral intake of food AGE
Macrovascular (brachial ultrasound of flow mediated dilatation -FMD) will be measured at baseline (T0), as well as 90 (T90) and 180 (T180) minutes after each beverage. The hypothesis of our study is that an AGE-rich beverage acutely impairs FMD more than a beverage with a low AGE content.
1 secondary outcome
Postprandial Change from Baseline in Microcirculation (Laser-Doppler measurements of reactive hyperemia at the hand)
Time frame: Baseline, 90 and 180 min. following food AGE intake.
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 20 Oct 2011.
- Derived from this study: PubMed 23238657Stirban A, Kotsi P, Franke K, Strijowski U, Cai W, Gotting C, Tschoepe D. Acute macrovascular dysfunction in patients with type 2 diabetes induced by ingestion of advanced glycated beta-lactoglobulins. Diabetes Care. 2013 May;36(5):1278-82. doi: 10.2337/dc12-1489. Epub 2012 Dec 13.
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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.
Alin O Stirban, M.D. principal investigator
Profil Institute for Metabolic Research GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycated beta-lactoglobulins. and Non-glycated beta-lactoglobulins in people with Type 2 Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH 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 1 inclusion and 4 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 20 Oct 2011. 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?
Postprandial Change from Baseline in Flow Mediated Dilatation (time frame: Baseline, 90 and 180 min after oral intake of food AGE). 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 NCT01456026, 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 20 Oct 2011.