Diabetes Mellitus, Type 1
Conditions
Keywords
Type 1 Diabetes mellitus, Gastric Emptying, Insulin Infusion Pump
Brief summary
This study evaluates the prevalence of gastric emptying (GE) in type 1 diabetic patients (DM1) free of chronic complications in comparison with a group of healthy control subjects. The investigators will also assess the relationship between GE and glucose control (HbA1c, postprandial glucose variability), gut peptide hormones (GLP-1, GIP, and ghrelin), and gastrointestinal symptoms. In addition, in patients with delayed GE the investigators will investigate the effect of tailored pre-prandial insulin bolus administered by means of insulin pump in reducing postprandial glucose variability, evaluated through continuous glucose monitoring system.
Detailed description
Diabetic patients with a delayed GE will be studied in 2 separate occasions in euglycemic condition and under CGM. On both occasions, they will have to take a standard meal poor of lipids (rice 60 g; yellow squash 200 g; extra virgin olive oil 7 g; adult veal lean cuts 90 g; bananas 180 g; ordinary bread 75 g). On the first occasion pre-prandial insulin will be administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load. On the second occasion the amount of pre-prandial insulin will be the same as the first one test but fractioned into a double-wave bolus. The tailored insulin bolus will be defined according to the individual pattern of GE, as follows: * GE T1/2 121-180 min= 60% as bolus + 40% during following 2 h * GE T1/2 \>180 min= 40% as bolus + 60% during following 4 h Glycemic variability will be assessed by the means of Continuous Glucose Monitoring System and the following indexes of glucose variability will be calculated: number of hypoglycemic events, number of hyperglycemic events, standard deviation of glycemia, glycemia variation coefficient, mean range of daily glycemia, interquartile range, M value, mean amplitude of glycemic excursions (MAGE), low blood glucose index (LBGI), high blood glucose index (HBGI).
Interventions
gastric emptying rate for solid will be determined using the 13C-OBT. Breath samples will be taken before the meal and then at 15-min intervals for a period of 240 min postprandially. The 13C content will be determined by on-line gas chromatographic purification-isotope ratio mass spectrometry (ABCA; Europe Scientific, Crewe, UK). The 13CO2 excretion curves will be analyzed and the half-emptying time (t½) and lag phase (tlag) calculated.
OTHERgut hormones determination
blood sampling at 0, 15, 30, 60, 90, 120, 180 min for determination of plasma, glucagon and GI hormones (Ghrelin, GLP-1, GIP)
OTHERContinuous Glucose Monitoring
7 days Continuous Glucose Monitoring
DRUGInsulin single bolus
pre-prandial insulin administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load
DRUGInsulin double-wave bolus
pre-prandial insulin fractioned into a double-wave bolus
Sponsors
Federico II University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* DM1; * Use of insulin pump; * Disease duration ≥ 3 years.
Exclusion criteria
* Presence of chronic complications of DM (including cardiovascular autonomic neuropathy); * BMI ≥ 30 kg/m2; * Presence of chronic diseases other than DM1; * Diseases that interfere with GE; * Medications that interfere with blood glucose homeostasis (except insulin) and GE.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gastric emptying measure | 4 hours |
Secondary
| Measure | Time frame |
|---|---|
| gut hormones dosage | 3 hours |
| Continuous Glucose Monitoring | 7 days |
| postprandial glucose variability after single insulin bolus | 3 hours |
| postprandial glucose variability after double-wave insulin bolus | 3 hours |
Countries
Italy
Outcome results
None listed