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

Not Applicable

Completed

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

• Registration Number: NCT01572402
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief Summary

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').

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with type 2 diabetes	Bagueutte Cheese Gourmet (Crocodille)	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
Patients with type 2 diabetes	Cous-cous sandwich	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
Patients with type 2 diabetes	McCountry sandwich (McDonald's)	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
Healthy subjects	Bagueutte Cheese Gourmet (Crocodille)	Mean and women, age 30-70 years, no diabetes, no metabolic syndrome
Healthy subjects	Cous-cous sandwich	Mean and women, age 30-70 years, no diabetes, no metabolic syndrome
Healthy subjects	McCountry sandwich (McDonald's)	Mean and women, age 30-70 years, no diabetes, no metabolic syndrome

Primary Outcome Measures

Name	Time	Method
Postprandial oxidative stress	up to 2 months
Postprandial plasma concentrations of gastrointestinal peptides	up to 2 months

Secondary Outcome Measures

Name	Time	Method
Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides	up to 2 months
Postprandial plasma lipids	up to 2 months

Trial Locations

Locations (1)

Hana Kahleova; 🇨🇿 Praha, Czech Republic