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OpenTrials
Completed

NCT Number: NCT01572402

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

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').

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Postprandial Oxidative Stress

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hana Kahleova

Prague, 140 21, Czechia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bagueutte Cheese Gourmet (Crocodille)

Other

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

Other

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)

Other

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 outcomes

  1. Postprandial oxidative stress

    Time frame: up to 2 months

  2. Postprandial plasma concentrations of gastrointestinal peptides

    Time frame: up to 2 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 6, 2012
Registry last updated
May 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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