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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543684
• Other study ID #: Diabetes study
• Status: Completed
• Phase: N/A
• First received: September 3, 2015
• Last updated: September 4, 2015
• Start date: November 2013

Study information

• Verified date: September 2015
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Bioethics Committee of Harokopio University
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• ready to eat mixed meal 1
wild greens pie providing 50g of carbohydrates
• ready to eat mixed meal 2
chicken burgers with boiled broccoli and cauliflower providing 50g of carbohydrates
• ready to eat mixed meal 3
vegetable moussaka providing 50g of carbohydrates
• oral glucose load
glucose load providing 50g of carbohydrates

Locations

Country	Name	City	State
Greece	Harokopio University of Athens	Kallithea	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Harokopio University

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum glucose changes over time		fasting baseline glucose at time 0, then 30, 60, 90, and 120 minutes postprandial	No
Primary	serum insulin changes over time		fasting baseline insulin at time 0, then 30, 60, 90, and 120 minutes postprandial	No