Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals
1 other identifier
interventional
24
1 country
1
Brief Summary
The aim of the current study was to compare the effects of three ready-to-eat mixed meals, with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic response in patients with Type 2 diabetes mellitus (T2DM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 3, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedSeptember 7, 2015
September 1, 2015
1.4 years
September 3, 2015
September 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
serum glucose changes over time
fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial
serum insulin changes over time
fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial
Study Arms (4)
ready to eat mixed meal 1
EXPERIMENTALready to eat mixed meal 2
EXPERIMENTALready to eat mixed meal 3
EXPERIMENTALoral glucose load
EXPERIMENTALInterventions
wild greens pie providing 50g of carbohydrates
chicken burgers with boiled broccoli and cauliflower providing 50g of carbohydrates
vegetable moussaka providing 50g of carbohydrates
Eligibility Criteria
You may qualify if:
- Subjects are eligible if they are 45-75 years of age
- non-insulin-dependent T2DM with an elapsed time since diagnosis of more than 3 years
- Body Mass Index (BMI) value higher than 20 kg/m2
- HbA1c levels of 6.5 to 11%
You may not qualify if:
- insulin-dependent T2DM
- cardiovascular (i.e. coronary heart disease, stroke etc.)
- liver and/or renal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harokopio University of Athens
Kallithea, Attica, 17671, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yannis Manios, Associate Professor
Harokopio University, Athens
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 3, 2015
First Posted
September 7, 2015
Study Start
November 1, 2013
Primary Completion
April 1, 2015
Last Updated
September 7, 2015
Record last verified: 2015-09