Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals

Study Overview
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Brief Summary
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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
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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.

Official Title
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Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: ready to eat mixed meal 1
* Other: ready to eat mixed meal 2
* Other: ready to eat mixed meal 3
* Other: oral glucose load


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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% Exclusion Criteria: insulin-dependent T2DM cardiovascular (i.e. coronary heart disease, stroke etc.) liver and/or renal disease

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ready to eat mixed meal 1<br> | Other: ready to eat mixed meal 1<br>* wild greens pie providing 50g of carbohydrates<br>* Other names: Sunday's Catering Company;|
| Experimental: ready to eat mixed meal 2<br> | Other: ready to eat mixed meal 2<br>* chicken burgers with boiled broccoli and cauliflower providing 50g of carbohydrates<br>* Other names: Sunday's Catering Company;|
| Experimental: ready to eat mixed meal 3<br> | Other: ready to eat mixed meal 3<br>* vegetable moussaka providing 50g of carbohydrates<br>* Other names: Sunday's Catering Company;|
| Experimental: oral glucose load<br> | Other: oral glucose load<br>* glucose load providing 50g of carbohydrates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum glucose changes over time |  | fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial | 
| serum insulin changes over time |  | fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glycemic response, diabetes, insulinemic response, mixed meals, glycemic index