Diabetes Mellitus, Type 2NCT02543684
Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals
A study testing ready to eat mixed meal 1, ready to eat mixed meal 2 and ready to eat mixed meal 3 in people with Diabetes Mellitus, Type 2, run by Harokopio University at 1 site in Greece.
Trial summary
The aim of the current study was to compare the effects of three ready-to-eat mixed meals, with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic response in patients with Type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- ready to eat mixed meal 1, ready to eat mixed meal 2 and ready to eat mixed meal 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2013to Apr 2015
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible if they are 45-75 years of age
- non-insulin-dependent T2DM with an elapsed time since diagnosis of more than 3 years
- Body Mass Index (BMI) value higher than 20 kg/m2
- HbA1c levels of 6.5 to 11%
Who cannot join
- insulin-dependent T2DM
- cardiovascular (i.e. coronary heart disease, stroke etc.)
- liver and/or renal disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current study was to compare the effects of three ready-to-eat mixed meals, with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic response in patients with Type 2 diabetes mellitus (T2DM).
Read the detailed description
The current study followed a prospective, three-way, cross-over design. Twenty four patients with T2DM consumed three ready-to-eat mixed meals, i.e. "wild greens pie" (meal 1), "chicken burgers with boiled vegetables" (meal 2) and "vegetable moussaka" (meal 3) and an oral glucose load, all providing 50g of carbohydrates. Venous blood was collected at 0, 30, 60, 90 and 120 minutes postprandial for serum glucose and insulin measurements.
The test meals were consumed by study participants between 8:30 to 9:00 am and within 10-15 minutes under a researcher's supervision, following collection of the fasting blood sample. No parallel fluid intake was allowed. The portion size in the case of each one of the three test meals was adjusted to contain 50g of carbohydrates. However, the three test meals were considerably differentiating among them with respect to their content in calories and the remaining macronutrients.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- ready to eat mixed meal 1, ready to eat mixed meal 2, ready to eat mixed meal 3, oral glucose load
- Keywords
- glycemic response, diabetes, insulinemic response, mixed meals, glycemic index
- 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.
ready to eat mixed meal 1Other
Also called Sunday's Catering Company
wild greens pie providing 50g of carbohydrates
ready to eat mixed meal 2Other
Also called Sunday's Catering Company
chicken burgers with boiled broccoli and cauliflower providing 50g of carbohydrates
ready to eat mixed meal 3Other
Also called Sunday's Catering Company
vegetable moussaka providing 50g of carbohydrates
oral glucose loadOther
glucose load providing 50g of carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| ready to eat mixed meal 1 | Experimental | Not described Receives: Other: ready to eat mixed meal 1 |
| ready to eat mixed meal 2 | Experimental | Not described Receives: Other: ready to eat mixed meal 2 |
| ready to eat mixed meal 3 | Experimental | Not described Receives: Other: ready to eat mixed meal 3 |
| oral glucose load | Experimental | Not described Receives: Other: oral glucose load |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum glucose changes over time
Measured: fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial
serum insulin changes over time
Measured: fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startNov 2013
- Primary completionApr 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannis Manios, Harokopio University
- Investigators
- Yannis Manios, Associate Professor, Principal investigator, Harokopio University, Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543684
- Sponsor's protocol ID
- Diabetes study
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals
- ClinicalTrials.gov ID
- NCT02543684
- Acronym / sponsor ID
- Diabetes study
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- glycemic response, diabetes, insulinemic response, mixed meals, glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2015 (actual)
- First posted
- 7 Sep 2015 (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 aim of the current study was to compare the effects of three ready-to-eat mixed meals, with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic response in patients with Type 2 diabetes mellitus (T2DM).
Detailed description
The current study followed a prospective, three-way, cross-over design. Twenty four patients with T2DM consumed three ready-to-eat mixed meals, i.e. "wild greens pie" (meal 1), "chicken burgers with boiled vegetables" (meal 2) and "vegetable moussaka" (meal 3) and an oral glucose load, all providing 50g of carbohydrates. Venous blood was collected at 0, 30, 60, 90 and 120 minutes postprandial for serum glucose and insulin measurements.
The test meals were consumed by study participants between 8:30 to 9:00 am and within 10-15 minutes under a researcher's supervision, following collection of the fasting blood sample. No parallel fluid intake was allowed. The portion size in the case of each one of the three test meals was adjusted to contain 50g of carbohydrates. However, the three test meals were considerably differentiating among them with respect to their content in calories and the remaining macronutrients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ready to eat mixed meal 1 | Experimental | Other: ready to eat mixed meal 1 |
| ready to eat mixed meal 2 | Experimental | Other: ready to eat mixed meal 2 |
| ready to eat mixed meal 3 | Experimental | Other: ready to eat mixed meal 3 |
| oral glucose load | Experimental | Other: oral glucose load |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects are eligible if they are 45-75 years of age
- non-insulin-dependent T2DM with an elapsed time since diagnosis of more than 3 years
- Body Mass Index (BMI) value higher than 20 kg/m2
- HbA1c levels of 6.5 to 11%
Key exclusion criteria (3 listed)
- insulin-dependent T2DM
- cardiovascular (i.e. coronary heart disease, stroke etc.)
- liver and/or renal disease
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 |
|---|---|---|
| ready to eat mixed meal 1Also: Sunday's Catering Companywild greens pie providing 50g of carbohydrates | Other | ready to eat mixed meal 1 |
| ready to eat mixed meal 2Also: Sunday's Catering Companychicken burgers with boiled broccoli and cauliflower providing 50g of carbohydrates | Other | ready to eat mixed meal 2 |
| ready to eat mixed meal 3Also: Sunday's Catering Companyvegetable moussaka providing 50g of carbohydrates | Other | ready to eat mixed meal 3 |
| oral glucose loadglucose load providing 50g of carbohydrates | Other | oral glucose load |
Primary outcome
serum glucose changes over time
Time frame: fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial
serum insulin changes over time
Time frame: fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial
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 7 Sep 2015.
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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.
Yannis Manios, Associate Professor principal investigator
Harokopio University, Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ready to eat mixed meal 1, ready to eat mixed meal 2 and ready to eat mixed meal 3 in people with Diabetes Mellitus, Type 2, run by Harokopio University at 1 site in Greece.
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 3 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 7 Sep 2015. 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 Greece. 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?
serum glucose changes over time (time frame: fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial). 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?
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 7 Sep 2015.