Postprandial Insulin Secretion, Oxidative Stress and Gastrointestinal Peptides in Patients With Type 2 Diabetes Versus Healthy Subjects

Study Overview
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Brief Summary
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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
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Type 2 Diabetes, Postprandial Oxidative Stress

Intervention / Treatment
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* Other: Bagueutte Cheese Gourmet (Crocodille)
* Other: Cous-cous sandwich
* Other: McCountry sandwich (McDonald's)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: gravidity, lactation, drug abuse, insulin therapy

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with type 2 diabetes<br>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 | Other: Bagueutte Cheese Gourmet (Crocodille)<br>* 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.<br>Other: Cous-cous sandwich<br>* 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<br>Other: McCountry sandwich (McDonald's)<br>* 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%)<br>|
| Active Comparator: Healthy subjects<br>Mean and women, age 30-70 years, no diabetes, no metabolic syndrome | Other: Bagueutte Cheese Gourmet (Crocodille)<br>* 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.<br>Other: Cous-cous sandwich<br>* 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<br>Other: McCountry sandwich (McDonald's)<br>* 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%)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial oxidative stress |  | up to 2 months | 
| Postprandial plasma concentrations of gastrointestinal peptides |  | up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides |  | up to 2 months | 
| Postprandial plasma lipids |  | up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Gastrointestinal peptides, Insulin secretion, Oxidative stress, Plasma lipids, Postprandial, Type 2 diabetes