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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: ready to eat mixed meal 1; Other: ready to eat mixed meal 3; Other: oral glucose load; Other: ready to eat mixed meal 2

• Registration Number: NCT02543684
• Lead Sponsor: Harokopio University

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.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2015-04
• Status Verified: 2015-09
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-04
• Last Update Submitted: 2015-09-04
• Study First Posted: 2015-09-07
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ready to eat mixed meal 1	ready to eat mixed meal 1	-
ready to eat mixed meal 3	ready to eat mixed meal 3	-
oral glucose load	oral glucose load	-
ready to eat mixed meal 2	ready to eat mixed meal 2	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Harokopio University of Athens; 🇬🇷 Kallithea, Attica, Greece