Type 2 DiabetesNCT01572402
Postprandial Insulin Secretion, Oxidative Stress and Gastrointestinal Peptides in Patients With Type 2 Diabetes Versus Healthy Subjects
A study testing Bagueutte Cheese Gourmet (Crocodille), Cous-cous sandwich and McCountry sandwich (McDonald's) in people with Type 2 Diabetes and Postprandial Oxidative Stress, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
Insulin secretion, plasma lipids, oxidative stress markers and gastrointestinal peptides will be measured in patients with type 2 diabetes versus healthy subjects in a fasting status and in response to standard meals (at times 0', 30', 60', 120' and 180'). Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Postprandial Oxidative Stress
- What is being tested?
- Bagueutte Cheese Gourmet (Crocodille), Cous-cous sandwich and McCountry sandwich (McDonald's)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2012to May 2012
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 individuals with type 2 diabetes treated by diet only or oral hypogylycemic agents,
- diabetes duration at least 1 year,
- both men and women,
- age 30-65 years,
- BMI 27-50 kg/m². The subjects will be explained aims, methods and risks of the study and they will sign informed consent
Who cannot join
- gravidity,
- lactation,
- drug abuse,
- insulin therapy
Trial locations and contacts
1 site in 1 country.
About this study
Insulin secretion, plasma lipids, oxidative stress markers and gastrointestinal peptides will be measured in patients with type 2 diabetes versus healthy subjects in a fasting status and in response to standard meals (at times 0', 30', 60', 120' and 180').
- Conditions
- Type 2 Diabetes, Postprandial Oxidative Stress
- Being tested
- Bagueutte Cheese Gourmet (Crocodille), Cous-cous sandwich, McCountry sandwich (McDonald's)
- Keywords
- Diet, Gastrointestinal peptides, Insulin secretion, Oxidative stress, Plasma lipids, Postprandial, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bagueutte Cheese Gourmet (Crocodille)Other
180g, energy 452.8 Kcal/1895.7 kJ, composition: carbohydrates 49,2 g (44,55%), proteins 18,5 g (16,74%), lipids 18,8 g (38,7%), of which saturated 6,8 g, monounsaturated 6,0 g, polyunsaturated 5,0 g.
Cous-cous sandwichOther
235 g, energy 455,88 Kcal /1907,4 kJ, composition: carbohydrates 59,54 g (52,24%), proteins 12,47 g (10,57% %), lipids 18,85 g (37,31%), of which saturated 6,2 g, monounsaturated 11,49 g, polyunsaturated 28,26 g
McCountry sandwich (McDonald's)Other
150g, 455 kcal/1903,72 kJ, composition: carbohydrates 31 g (27,25%), proteins 24 g (21,1%), lipids 26 g (51,43%), of which saturated 10 g (38,45%)
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes | Experimental | Study group: 40 individuals with type 2 diabetes treated by diet and/or oral hypogylycemic agents, diabetes duration at least 1 year, both men and women, age 30-65 years, BMI 27-50 kg/m². The subjects will be explained aims, methods and risks of the study and they will sign informed consent Receives: Other: Bagueutte Cheese Gourmet (Crocodille); Other: Cous-cous sandwich; Other: McCountry sandwich (McDonald's) |
| Healthy subjects | Active comparator | Mean and women, age 30-70 years, no diabetes, no metabolic syndrome Receives: Other: Bagueutte Cheese Gourmet (Crocodille); Other: Cous-cous sandwich; Other: McCountry sandwich (McDonald's) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial oxidative stress
Measured: up to 2 months
Postprandial plasma concentrations of gastrointestinal peptides
Measured: up to 2 months
Secondary outcomes (2)
Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides
Measured: up to 2 months
Postprandial plasma lipids
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hana Kahleova, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572402
- Sponsor's protocol ID
- 5206
- Status last verified
- May 2012
- First submitted
- 3 Apr 2012
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Belinova L, Kahleova H, Malinska H, Topolcan O, Vrzalova J, Oliyarnyk O, Kazdova L, Hill M, Pelikanova T. Differential acute postprandial effects of processed meat and isocaloric vegan meals on the gastrointestinal hormone response in subjects suffering from type 2 diabetes and healthy controls: a randomized crossover study. PLoS One. 2014 Sep 15;9(9):e107561. doi: 10.1371/journal.pone.0107561. eCollection 2014.
PubMed 25222490Malinska H, Kahleova H, Topolcan O, Vrzalova J, Oliyarnyk O, Kazdova L, Belinova L, Hill M, Pelikanova T. Postprandial oxidative stress and gastrointestinal hormones: is there a link? PLoS One. 2014 Aug 20;9(8):e103565. doi: 10.1371/journal.pone.0103565. eCollection 2014.
PubMed 25141237
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Insulin Secretion, Oxidative Stress and Gastrointestinal Peptides in Patients With Type 2 Diabetes Versus Healthy Subjects
- ClinicalTrials.gov ID
- NCT01572402
- Acronym / sponsor ID
- 5206
- Conditions
- Type 2 Diabetes, Postprandial Oxidative Stress
- Keywords
- Diet, Gastrointestinal peptides, Insulin secretion, Oxidative stress, Plasma lipids, Postprandial, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 6 Apr 2012 (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.
Insulin secretion, plasma lipids, oxidative stress markers and gastrointestinal peptides will be measured in patients with type 2 diabetes versus healthy subjects in a fasting status and in response to standard meals (at times 0', 30', 60', 120' and 180').
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes | Experimental | Other: Bagueutte Cheese Gourmet (Crocodille), Other: Cous-cous sandwich, Other: McCountry sandwich (McDonald's)Study group: 40 individuals with type 2 diabetes treated by diet and/or oral hypogylycemic agents, diabetes duration at least 1 year, both men and women, age 30-65 years, BMI 27-50 kg/m². The subjects will be explained aims, methods and risks of the study and they will sign informed consent |
| Healthy subjects | Active comparator | Other: Bagueutte Cheese Gourmet (Crocodille), Other: Cous-cous sandwich, Other: McCountry sandwich (McDonald's)Mean and women, age 30-70 years, no diabetes, no metabolic syndrome |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 40 individuals with type 2 diabetes treated by diet only or oral hypogylycemic agents,
- diabetes duration at least 1 year,
- both men and women,
- age 30-65 years,
- BMI 27-50 kg/m². The subjects will be explained aims, methods and risks of the study and they will sign informed consent
Key exclusion criteria (4 listed)
- gravidity,
- lactation,
- drug abuse,
- insulin therapy
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 |
|---|---|---|
| Bagueutte Cheese Gourmet (Crocodille)180g, energy 452.8 Kcal/1895.7 kJ, composition: carbohydrates 49,2 g (44,55%), proteins 18,5 g (16,74%), lipids 18,8 g (38,7%), of which saturated 6,8 g, monounsaturated 6,0 g, polyunsaturated 5,0 g. | Other | Healthy subjects, Patients with type 2 diabetes |
| Cous-cous sandwich235 g, energy 455,88 Kcal /1907,4 kJ, composition: carbohydrates 59,54 g (52,24%), proteins 12,47 g (10,57% %), lipids 18,85 g (37,31%), of which saturated 6,2 g, monounsaturated 11,49 g, polyunsaturated 28,26 g | Other | Healthy subjects, Patients with type 2 diabetes |
| McCountry sandwich (McDonald's)150g, 455 kcal/1903,72 kJ, composition: carbohydrates 31 g (27,25%), proteins 24 g (21,1%), lipids 26 g (51,43%), of which saturated 10 g (38,45%) | Other | Healthy subjects, Patients with type 2 diabetes |
Primary outcome
Postprandial oxidative stress
Time frame: up to 2 months
Postprandial plasma concentrations of gastrointestinal peptides
Time frame: up to 2 months
2 secondary outcomes
Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides
Time frame: up to 2 months
Postprandial plasma lipids
Time frame: up to 2 months
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 10 May 2012.
- Derived from this study: PubMed 25222490Belinova L, Kahleova H, Malinska H, Topolcan O, Vrzalova J, Oliyarnyk O, Kazdova L, Hill M, Pelikanova T. Differential acute postprandial effects of processed meat and isocaloric vegan meals on the gastrointestinal hormone response in subjects suffering from type 2 diabetes and healthy controls: a randomized crossover study. PLoS One. 2014 Sep 15;9(9):e107561. doi: 10.1371/journal.pone.0107561. eCollection 2014.
- Derived from this study: PubMed 25141237Malinska H, Kahleova H, Topolcan O, Vrzalova J, Oliyarnyk O, Kazdova L, Belinova L, Hill M, Pelikanova T. Postprandial oxidative stress and gastrointestinal hormones: is there a link? PLoS One. 2014 Aug 20;9(8):e103565. doi: 10.1371/journal.pone.0103565. eCollection 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bagueutte Cheese Gourmet (Crocodille), Cous-cous sandwich and McCountry sandwich (McDonald's) in people with Type 2 Diabetes and Postprandial Oxidative Stress, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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 5 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 10 May 2012. 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 Czechia. 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 oxidative stress (time frame: up to 2 months). The study lists 2 primary outcomes in all. 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 NCT01572402, which also lists 2 linked publications.
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 10 May 2012.