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

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Postprandial Oxidative Stress
• Intervention / Treatment: Other: Bagueutte Cheese Gourmet (Crocodille); Other: Cous-cous sandwich; Other: McCountry sandwich (McDonald's)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czech Republic
  • Praha, Czech Republic, 140 21
    • Hana Kahleova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other: 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; 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%)
Active Comparator: Healthy subjects; Mean and women, age 30-70 years, no diabetes, no metabolic syndrome	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.; Other: 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; 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%)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute for Clinical and Experimental Medicine

Publications and helpful links

General 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.
• Malinska 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimate): April 6, 2012

Study Record Updates

• Last Update Posted (Estimate): May 10, 2012
• Last Update Submitted That Met QC Criteria: May 9, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Oxidative stress; Type 2 diabetes; Diet; Postprandial; Insulin secretion; Gastrointestinal peptides; Plasma lipids
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 5206