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Mixed Meal Test in Type 1 Diabetes: Optimization of Artificial Pancreas-Pilot Study

NCT01800734 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-11-19

No results posted yet for this study

Summary

Physiology studies will be performed in patients with type 1 diabetes to define during a standardized mixed meal test: 1. The relationship between fast insulin analogue administration by i.v. infusion or by subcutaneous pumps and plasma insulin concentration and tissue insulin action; 2. The relationship between insulin action, glucose fluxes and glucose concentration, the latter one as measured in plasma or estimated by a s.c. glucose-sensor; 3. The concentration curves of some potential modifiers of the glucose-insulin system (i.e.: glucagon, incretin hormones, free fatty and amino acids).

On the basis of these data, in silico phenocopies of the patients (virtual patients) will be created to measure the glucose control coefficients, which quantify the role played by each component of the glucose-insulin system on glucose concentration.

One final purpose of this research is to develop and to optimize an algorithm able to integrate continuous glucose monitoring with continuous subcutaneous fast insulin analogue infusion, known as closed-loop control (CLC) or artificial pancreas.

Conditions

  • Diabetes Mellitus Type 1

Interventions

OTHER

Clamp-Mixed Meal Arm

Standard clinical parameters will be assessed in all patients. Metabolic tests: A. Euglycemic insulin clamp. A standard euglycemic insulin clamp will be carried out to assess insulin sensitivity, as previously described (1). B. Mixed meal test. All participants will ingest a standardized mixed meal and will be monitored for 300 minutes thereafter. Right before meal ingestion, a s.c. fast insulin analogue bolus will be administered by the pump This test will determine the time courses of: 1\. plasma glucose, 2.13C/12C glucose ratio (hence, meal-derived and endogenous glucose), 3. insulin, 4. free fatty acids, 5. aminoacids, 6. glucagon, 7. incretin hormones 8. glucose control coefficients (CCs) during a mixed meal.

Sponsors & Collaborators

  • Universita di Verona

    collaborator OTHER

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Principal Investigators

  • Riccardo C Bonadonna, Assoc Prof · Division of Endocrinology and Metabolic Diseases, University Hospital of Verona

  • Enzo Bonora, Full Prof · Division of Endocrinology and Metabolic Diseases, University Hospital of Verona

  • Maddalena Trombetta, Asst Prof · Division of Endocrinology and Metabolic Diseases, University Hospital of Verona

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-02-28
Completion
2015-02-28

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 NCT01800734 on ClinicalTrials.gov