NCT02365740

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 19, 2015

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

February 4, 2015

Last Update Submit

February 18, 2015

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes mellitusGastric EmptyingInsulin Infusion Pump

Outcome Measures

Primary Outcomes (1)

  • gastric emptying measure

    4 hours

Secondary Outcomes (4)

  • 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

Study Arms (2)

Cases

EXPERIMENTAL

gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus

Other: gastric emptying testOther: gut hormones determinationOther: Continuous Glucose MonitoringDrug: Insulin single bolusDrug: Insulin double-wave bolus

Controls

SHAM COMPARATOR

gastric emptying test gut hormones determination

Other: gastric emptying testOther: gut hormones determination

Interventions

gastric emptying testOTHER

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.

CasesControls
gut hormones determinationOTHER

blood sampling at 0, 15, 30, 60, 90, 120, 180 min for determination of plasma, glucagon and GI hormones (Ghrelin, GLP-1, GIP)

CasesControls
Continuous Glucose MonitoringOTHER

7 days Continuous Glucose Monitoring

Cases
Insulin single bolusDRUG

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

Cases
Insulin double-wave bolusDRUG

pre-prandial insulin fractioned into a double-wave bolus

Cases

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • DM1;
  • Use of insulin pump;
  • Disease duration ≥ 3 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of "Medicina Clinica e Chirurgia" of Federico II University

Naples, Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 19, 2015

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2016

Last Updated

February 19, 2015

Record last verified: 2014-11

Locations

IT(1)