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Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
ready to eat mixed meal 1
ready to eat mixed meal 2
ready to eat mixed meal 3
oral glucose load
Sponsored by
Harokopio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring glycemic response, diabetes, insulinemic response, mixed meals, glycemic index

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • insulin-dependent T2DM
  • cardiovascular (i.e. coronary heart disease, stroke etc.)
  • liver and/or renal disease

Sites / Locations

  • Harokopio University of Athens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

ready to eat mixed meal 1

ready to eat mixed meal 2

ready to eat mixed meal 3

oral glucose load

Arm Description

Outcomes

Primary Outcome Measures

serum glucose changes over time
serum insulin changes over time

Secondary Outcome Measures

Full Information

First Posted
September 3, 2015
Last Updated
September 4, 2015
Sponsor
Harokopio University
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1. Study Identification

Unique Protocol Identification Number
NCT02543684
Brief Title
Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals
Official Title
Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University

4. Oversight

5. Study Description

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).
Detailed Description
The current study followed a prospective, three-way, cross-over design. Twenty four patients with T2DM consumed three ready-to-eat mixed meals, i.e. "wild greens pie" (meal 1), "chicken burgers with boiled vegetables" (meal 2) and "vegetable moussaka" (meal 3) and an oral glucose load, all providing 50g of carbohydrates. Venous blood was collected at 0, 30, 60, 90 and 120 minutes postprandial for serum glucose and insulin measurements. The test meals were consumed by study participants between 8:30 to 9:00 am and within 10-15 minutes under a researcher's supervision, following collection of the fasting blood sample. No parallel fluid intake was allowed. The portion size in the case of each one of the three test meals was adjusted to contain 50g of carbohydrates. However, the three test meals were considerably differentiating among them with respect to their content in calories and the remaining macronutrients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
glycemic response, diabetes, insulinemic response, mixed meals, glycemic index

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ready to eat mixed meal 1
Arm Type
Experimental
Arm Title
ready to eat mixed meal 2
Arm Type
Experimental
Arm Title
ready to eat mixed meal 3
Arm Type
Experimental
Arm Title
oral glucose load
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
ready to eat mixed meal 1
Other Intervention Name(s)
Sunday's Catering Company
Intervention Description
wild greens pie providing 50g of carbohydrates
Intervention Type
Other
Intervention Name(s)
ready to eat mixed meal 2
Other Intervention Name(s)
Sunday's Catering Company
Intervention Description
chicken burgers with boiled broccoli and cauliflower providing 50g of carbohydrates
Intervention Type
Other
Intervention Name(s)
ready to eat mixed meal 3
Other Intervention Name(s)
Sunday's Catering Company
Intervention Description
vegetable moussaka providing 50g of carbohydrates
Intervention Type
Other
Intervention Name(s)
oral glucose load
Intervention Description
glucose load providing 50g of carbohydrates
Primary Outcome Measure Information:
Title
serum glucose changes over time
Time Frame
fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial
Title
serum insulin changes over time
Time Frame
fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% Exclusion Criteria: insulin-dependent T2DM cardiovascular (i.e. coronary heart disease, stroke etc.) liver and/or renal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannis Manios, Associate Professor
Organizational Affiliation
Harokopio University, Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harokopio University of Athens
City
Kallithea
State/Province
Attica
ZIP/Postal Code
17671
Country
Greece

12. IPD Sharing Statement

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Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals

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