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

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ClinicalTrials.gov Identifier: NCT01572402
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : May 10, 2012
Sponsor:
Information provided by (Responsible Party):
Hana Kahleova, 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').

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Postprandial Oxidative Stress Other: Bagueutte Cheese Gourmet (Crocodille) Other: Cous-cous sandwich Other: McCountry sandwich (McDonald's) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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%)



Primary Outcome Measures :
  1. Postprandial oxidative stress [ Time Frame: up to 2 months ]
  2. Postprandial plasma concentrations of gastrointestinal peptides [ Time Frame: up to 2 months ]

Secondary Outcome Measures :
  1. Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides [ Time Frame: up to 2 months ]
  2. Postprandial plasma lipids [ Time Frame: up to 2 months ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572402


Locations
Czech Republic
Hana Kahleova
Praha, Czech Republic, 140 21
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hana Kahleova, Principal Investigator, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT01572402     History of Changes
Other Study ID Numbers: 5206
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012

Keywords provided by Hana Kahleova, Institute for Clinical and Experimental Medicine:
Diet
Gastrointestinal peptides
Insulin secretion
Oxidative stress
Plasma lipids
Postprandial
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases