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Postprandial Blood Glucose Control and Gastric Emptying in Type 1 Diabetes: Pathogenetic Factors and Therapeutic Options

NCT02365740 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-02-19

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

OTHER

gastric emptying test

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.

OTHER

gut 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)

OTHER

Continuous Glucose Monitoring

7 days Continuous Glucose Monitoring

DRUG

Insulin single bolus

pre-prandial insulin administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load

DRUG

Insulin double-wave bolus

pre-prandial insulin fractioned into a double-wave bolus

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-11-30
Completion
2016-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02365740 on ClinicalTrials.gov