An interventional study of gastric emptying test and gut hormones determination in Diabetes Mellitus, Type 1, sponsored by Federico II University. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-19.
Sponsored by Federico II University · Not applicable, Interventional, and Treatment
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.
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:
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus
Other: gastric emptying test · Other: gut hormones determination · Other: Continuous Glucose Monitoring · Drug: Insulin single bolus · Drug: Insulin double-wave bolus
gastric emptying test gut hormones determination
Other: gastric emptying test · Other: gut hormones determination
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.
blood sampling at 0, 15, 30, 60, 90, 120, 180 min for determination of plasma, glucagon and GI hormones (Ghrelin, GLP-1, GIP)
7 days Continuous Glucose Monitoring
pre-prandial insulin administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load
pre-prandial insulin fractioned into a double-wave bolus
gastric emptying measure
Time frame: 4 hours
gut hormones dosage
Time frame: 3 hours
Continuous Glucose Monitoring
Time frame: 7 days
postprandial glucose variability after single insulin bolus
Time frame: 3 hours
postprandial glucose variability after double-wave insulin bolus
Time frame: 3 hours
This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Federico II University