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Completed

NCT Number: NCT02543684

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

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).

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harokopio University of Athens

Kallithea, Attica, 17671, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ready to eat mixed meal 1

Other

wild greens pie providing 50g of carbohydrates

Other names: Sunday's Catering Company

ready to eat mixed meal 2

Other

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

Other names: Sunday's Catering Company

ready to eat mixed meal 3

Other

vegetable moussaka providing 50g of carbohydrates

Other names: Sunday's Catering Company

oral glucose load

Other

glucose load providing 50g of carbohydrates

Primary outcomes

  1. serum glucose changes over time

    Time frame: fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial

  2. serum insulin changes over time

    Time frame: fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
First posted
Sep 7, 2015
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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