Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hana Kahleova, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT01572402
First received: April 3, 2012
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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

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

Resource links provided by NLM:


Further study details as provided by Institute for Clinical and Experimental Medicine:

Primary Outcome Measures:
  • Postprandial oxidative stress [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
  • Postprandial plasma concentrations of gastrointestinal peptides [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
  • Postprandial plasma lipids [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%)

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572402

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

No publications provided by Institute for Clinical and Experimental Medicine

Additional 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
Study First Received: April 3, 2012
Last Updated: May 9, 2012
Health Authority: Czech Republic: Institute for Clinical and Experimental Medicine

Keywords provided by 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
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 19, 2014