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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-05-31

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').

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Detailed Description

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Conditions

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Type 2 Diabetes Postprandial Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients with type 2 diabetes

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

Group Type EXPERIMENTAL

Cous-cous sandwich

Intervention Type OTHER

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)

Intervention Type 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%)

Bagueutte Cheese Gourmet (Crocodille)

Intervention Type 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.

Healthy subjects

Mean and women, age 30-70 years, no diabetes, no metabolic syndrome

Group Type ACTIVE_COMPARATOR

Cous-cous sandwich

Intervention Type OTHER

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)

Intervention Type 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%)

Bagueutte Cheese Gourmet (Crocodille)

Intervention Type 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.

Interventions

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Cous-cous sandwich

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

Intervention Type OTHER

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%)

Intervention Type OTHER

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.

Intervention Type OTHER

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