Effectiveness of Carbohydrate Counting Method With Mixed Meals

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928016
• Other study ID #: HRBD 11th Session 6/4/2014 NHA
• Status: Completed
• Phase: N/A
• First received: October 6, 2016
• Last updated: October 8, 2016
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Agricultural University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Agricultural University of Athens	Harokopio University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No