NCT01572402

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').

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 10, 2012

Status Verified

May 1, 2012

Enrollment Period

4 months

First QC Date

April 3, 2012

Last Update Submit

May 9, 2012

Conditions

Type 2 DiabetesPostprandial Oxidative Stress

Keywords

DietGastrointestinal peptidesInsulin secretionOxidative stressPlasma lipidsPostprandialType 2 diabetes

Outcome Measures

Primary Outcomes (2)

  • Postprandial oxidative stress

    up to 2 months

  • Postprandial plasma concentrations of gastrointestinal peptides

    up to 2 months

Secondary Outcomes (2)

  • Postprandial insulin secretion - relationship to oxidative stress and gastrointestinal peptides

    up to 2 months

  • Postprandial plasma lipids

    up to 2 months

Study Arms (2)

Patients with type 2 diabetes

EXPERIMENTAL

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)Other: Cous-cous sandwichOther: McCountry sandwich (McDonald's)

Healthy subjects

ACTIVE COMPARATOR

Mean and women, age 30-70 years, no diabetes, no metabolic syndrome

Other: Bagueutte Cheese Gourmet (Crocodille)Other: Cous-cous sandwichOther: McCountry sandwich (McDonald's)

Interventions

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.

Healthy subjectsPatients with type 2 diabetes
Cous-cous sandwichOTHER

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

Healthy subjectsPatients with type 2 diabetes
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%)

Healthy subjectsPatients with type 2 diabetes

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • gravidity,
  • lactation,
  • drug abuse,
  • insulin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hana Kahleova

Prague, 140 21, Czechia

Location

Related Publications (2)

  • 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.

    PMID: 25222490DERIVED

  • 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.

    PMID: 25141237DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 6, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 10, 2012

Record last verified: 2012-05

Locations

CZ(1)