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

September 4, 2015 updated by: Yannis Manios, Harokopio University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Kallithea, Attica, Greece, 17671
        • Harokopio University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ready to eat mixed meal 1
Other: ready to eat mixed meal 1
wild greens pie providing 50g of carbohydrates
Other Names:
  • Sunday's Catering Company
Experimental: ready to eat mixed meal 2
Other: ready to eat mixed meal 2
chicken burgers with boiled broccoli and cauliflower providing 50g of carbohydrates
Other Names:
  • Sunday's Catering Company
Experimental: ready to eat mixed meal 3
Other: ready to eat mixed meal 3
vegetable moussaka providing 50g of carbohydrates
Other Names:
  • Sunday's Catering Company
Experimental: oral glucose load
Other: oral glucose load
glucose load providing 50g of carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum glucose changes over time
Time Frame: fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial
fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial
serum insulin changes over time
Time Frame: fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial
fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diabetes study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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