Postprandial Insulin Secretion, Oxidative Stress and Gastrointestinal Peptides in Patients With Type 2 Diabetes Versus Healthy Subjects
Primary Purpose
Type 2 Diabetes, Postprandial Oxidative Stress
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Bagueutte Cheese Gourmet (Crocodille)
Cous-cous sandwich
McCountry sandwich (McDonald's)
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes focused on measuring Diet, Gastrointestinal peptides, Insulin secretion, Oxidative stress, Plasma lipids, Postprandial, Type 2 diabetes
Eligibility Criteria
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
Sites / Locations
- Hana Kahleova
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with type 2 diabetes
Healthy subjects
Arm Description
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
Mean and women, age 30-70 years, no diabetes, no metabolic syndrome
Outcomes
Primary Outcome Measures
Postprandial oxidative stress
Postprandial plasma concentrations of gastrointestinal peptides
Secondary Outcome Measures
Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides
Postprandial plasma lipids
Full Information
NCT ID
NCT01572402
First Posted
April 3, 2012
Last Updated
May 9, 2012
Sponsor
Institute for Clinical and Experimental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01572402
Brief Title
Postprandial Insulin Secretion, Oxidative Stress and Gastrointestinal Peptides in Patients With Type 2 Diabetes Versus Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Clinical and Experimental Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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').
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Postprandial Oxidative Stress
Keywords
Diet, Gastrointestinal peptides, Insulin secretion, Oxidative stress, Plasma lipids, Postprandial, Type 2 diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with type 2 diabetes
Arm Type
Experimental
Arm Description
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
Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm Description
Mean and women, age 30-70 years, no diabetes, no metabolic syndrome
Intervention Type
Other
Intervention Name(s)
Bagueutte Cheese Gourmet (Crocodille)
Intervention Description
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
Intervention Name(s)
Cous-cous sandwich
Intervention Description
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
Intervention Name(s)
McCountry sandwich (McDonald's)
Intervention Description
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%)
Primary Outcome Measure Information:
Title
Postprandial oxidative stress
Time Frame
up to 2 months
Title
Postprandial plasma concentrations of gastrointestinal peptides
Time Frame
up to 2 months
Secondary Outcome Measure Information:
Title
Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides
Time Frame
up to 2 months
Title
Postprandial plasma lipids
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hana Kahleova
City
Praha
ZIP/Postal Code
140 21
Country
Czech Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
25222490
Citation
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.
Results Reference
derived
PubMed Identifier
25141237
Citation
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.
Results Reference
derived
Learn more about this trial
Postprandial Insulin Secretion, Oxidative Stress and Gastrointestinal Peptides in Patients With Type 2 Diabetes Versus Healthy Subjects
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