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Impact of Meal Composition and Alcohol Consumption on Postprandial Glycemic Control in Subjects With Type 1 Diabetes

NCT03320993 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-03-09

No results posted yet for this study

Summary

Postprandial glucose control is a challenging issue in everyday diabetes care. Indeed, excessive postprandial glucose excursions are the major contributors to plasma glucose (PG) variability in subjects with type 1 diabetes (T1DM). In addition, the poor reproducibility of postprandial glucose response is burdensome for patients and healthcare professionals.

To date, the majority of prandial insulin dosing algorithms for subjects with T1DM considers only the carbohydrate (CHO) content of the meal. However, there is evidence (although with a certain degree of heterogeneity) that meal composition significantly affects postprandial glucose control, contributing to glycemic variability. Moreover, despite the high prevalence of alcohol consumption among patients with T1DM (about 30%, similar to that of the general population), data regarding its effect on the postprandial period are very limited.

This project will evaluate the effect of meal composition and alcohol consumption on postprandial glucose control in subjects with T1DM under intensive insulin treatment.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

OTHER

Mixed meal with different macronutrient composition

A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given

Sponsors & Collaborators

  • Hospital Francesc de Borja, Gandia, Spain

    collaborator UNKNOWN

  • Ministerio de Economía y Competitividad, Spain

    collaborator OTHER_GOV

  • Jorge Bondia

    lead OTHER

Principal Investigators

  • Paolo Rossetti, PhD · Hospital Francesc de Borja, Gandia

  • Jorge Bondia Company, PhD · Universitat Politècnica de València

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2020-01-23
Completion
2020-01-31

Countries

  • Spain

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 NCT03320993 on ClinicalTrials.gov