CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Mixed meal with different macronutrient compositionother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03320993
NCT03320993N/ACompleted

Evaluación Del Impacto de la composición Nutricional de la Ingesta y Del Consumo de Alcohol en el Control glucémico Postprandial en Pacientes Con Diabetes Tipo 1

Jorge Bondia·interventional·Posted Oct 25, 2017·Updated Mar 9, 2020

In Brief

A clinical study evaluating Mixed meal with different macronutrient composition for Diabetes Mellitus, Type 1. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 25, 2017
Enrollment StartOct 25, 2018
Primary CompletionJan 23, 2020
Study CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.7 years ago

Interventions

Mixed meal with different macronutrient compositionother

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