Clinical trial NCT02928016: Effectiveness of Carbohydrate Counting Method With Mixed Meals
Official title: Effectiveness of the Carbohydrate Counting Method on Postprandial Glucose Concentrations After Consumption of Mixed Meals in Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: carbohydrate counting method
protein
fat
glucose
type 1 diabetes
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
Collaborators: name: Harokopio University
First posted: 2016-10-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Capillary blood glucose
timeFrame: 195 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Agricultural University of Athens
name: Aimilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References: