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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572402
• Other study ID #: 5206
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: May 9, 2012
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Institute for Clinical and Experimental Medicine
• Study type: Interventional

Clinical Trial 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').

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Postprandial Oxidative Stress
• Type 2 Diabetes

Intervention

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.
• 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
• 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%)

Locations

Country	Name	City	State
Czech Republic	Hana Kahleova	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial oxidative stress		up to 2 months	No
Primary	Postprandial plasma concentrations of gastrointestinal peptides		up to 2 months	No
Secondary	Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides		up to 2 months	No
Secondary	Postprandial plasma lipids		up to 2 months	No