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

NCT ID: NCT02543684

Last Updated: 2015-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ready to eat mixed meal 1

Group Type EXPERIMENTAL

ready to eat mixed meal 1

Intervention Type OTHER

wild greens pie providing 50g of carbohydrates

ready to eat mixed meal 2

Group Type EXPERIMENTAL

ready to eat mixed meal 2

Intervention Type OTHER

chicken burgers with boiled broccoli and cauliflower providing 50g of carbohydrates

ready to eat mixed meal 3

Group Type EXPERIMENTAL

ready to eat mixed meal 3

Intervention Type OTHER

vegetable moussaka providing 50g of carbohydrates

oral glucose load

Group Type EXPERIMENTAL

oral glucose load

Intervention Type OTHER

glucose load providing 50g of carbohydrates

Interventions

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ready to eat mixed meal 1

wild greens pie providing 50g of carbohydrates

Intervention Type OTHER

ready to eat mixed meal 2

chicken burgers with boiled broccoli and cauliflower providing 50g of carbohydrates

Intervention Type OTHER

ready to eat mixed meal 3

vegetable moussaka providing 50g of carbohydrates

Intervention Type OTHER

oral glucose load

glucose load providing 50g of carbohydrates

Intervention Type OTHER

Other Intervention Names

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Sunday's Catering Company Sunday's Catering Company Sunday's Catering Company

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harokopio University

OTHER

Sponsor Role lead

Responsible Party

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Yannis Manios

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yannis Manios, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Harokopio University, Athens

Locations

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Harokopio University of Athens

Kallithea, Attica, Greece

Site Status

Countries

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Greece

Other Identifiers

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Diabetes study

Identifier Type: -

Identifier Source: org_study_id

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