Effectiveness of Carbohydrate Counting Method With Mixed Meals

Effectiveness of the Carbohydrate Counting Method on Postprandial Glucose Concentrations After Consumption of Mixed Meals in Adults With Type 1 Diabetes

In a randomized, cross-over designed study, the investigators examined the effectiveness of the carbohydrate counting method after consumption of mixed meals typical of the Greek cuisine with various protein and fat contents in a sample of people with type 1 diabetes (DM1). The investigators also tried to further explore the effects of additional extra virgin olive oil (11 ml) on the glycemic response.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Mixed meal 1; Other: Mixed meal 2; Other: Mixed meal 3; Other: Mixed meal 4; Other: Mixed meal 5; Other: Mixed meal 6

Detailed Description

A total of 20 adults with type 1 diabetes on intensive insulin therapy consumed three mixed meals at noon between 1200 and 1300 hours, with and without the addition of 11 ml extra virgin oil, in random order. One week before entering the study, participants kept a detailed 7-day weighed food record with fingerprick blood glucose measurements pre-and-2hour post-meals for calculation of their carbohydrate (g) to insulin (units) ratio. Moreover, the individual correction factor was calculated. Thereafter, insulin requirements for the test meals were calculated based on the carbohydrate content of each dish and according to the personalised carbohydrate to insulin ratio. Postprandial glycemia was measured in capillary blood glucose samples at 30min intervals over 195min. For 24hr before each testing session, participants were asked to refrain from the consumption of alcohol and to maintain their usual physical activity pattern. On the day of testing, subjects were asked to consume their usual breakfast and abstain from food for at least 2 hours before their appointment. If blood glucose was >7.2 mmol/l at 1200, insulin was administered based on the individualised correction factor. If blood glucose was >10 mmol/l at the beginning of the testing session, insulin was administered to correct it and the subject was asked to return on another day. if hypoglycaemia occurred (defined as blood glucose level <3.8 mmol/l), the test session was stopped, the event was recorded and the patient treated appropriately. The on target 2hour postprandial blood glucose level was set between 3.9 and 10 mmol/l. Anthropometric measurements (body weight, waist and hip circumferences) were performed at every visit.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with type 1 diabetes
• Intensive insulin therapy
• HbA1c < 10%
• >2 years with diabetes

Exclusion Criteria:

• Food allergies
• Diabetic neuropathy
• Kidney disease
• Hematological disturbances
• Liver disease
• Uncontrolled hypo- or hyperthyroidism
• Arrhythmia
• Heart disease
• Cancer
• Serious mental illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mixed meal 1; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.	Other: Mixed meal 1; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed a dish made with thick pasta, minced meat and béchamel sauce and 20 g kalamata olives. The meal provided 794 kcal and contained approximately 500 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
Experimental: Mixed meal 2; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.	Other: Mixed meal 2; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed grilled chicken with vegetables.The meal provided 399 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
Experimental: Mixed meal 3; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.	Other: Mixed meal 3; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed baked giant beans and 20g kalamata olives. The meal provided 502 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
Experimental: Mixed meal 4; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.	Other: Mixed meal 4; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed a dish made with thick pasta, minced meat and béchamel sauce and 20 g kalamata olives and 11 ml extra virgin olive oil. The meal provided 893 kcal and contained approximately 600 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
Experimental: Mixed meal 5; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.	Other: Mixed meal 5; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed grilled chicken with vegetables and 11 ml extra virgin olive oil. The meal provided 497 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
Experimental: Mixed meal 6; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment and glycated haemoglobin (HbA1c) <10% consumed three ready-made standardised mixed meals (a dish made with thick pasta, minced meat and béchamel sauce, grilled chicken with vegetables and baked giant beans) with and without the addition of 11 ml of extra virgin olive oil within 20 minutes. No other food or drink (except for water) were consumed until the end of the trial period (total duration 195 minutes). Participants consumed all meals in random order during 6 consecutive visits with one week wash-out period in between visits.	Other: Mixed meal 6; 20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed baked giant beans and 20 g kalamata olives and 11 ml extra virgin olive oil. The meal provided 601 kcal and contained approximately 400 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capillary blood glucose	Clinically useful change in capillary blood glucose, defined as the restoration of glucose within normal limits during the first two hours and until the end of the trial	195 minutes

Collaborators and Investigators

• Sponsor: Agricultural University of Athens
• Collaborators: Harokopio University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (Estimate): October 7, 2016

Study Record Updates

• Last Update Posted (Estimate): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 8, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: type 1 diabetes; glucose; fat; protein; carbohydrate counting method
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: HRBD 11th Session 6/4/2014 NHA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No