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

March 6, 2020 updated by: Jorge Bondia

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized, prospective, single-centre (Hospital Francesc de Borja, Gandia, Spain), single-blind (analysis), three -way, crossover study on type 1 diabetic subjects (n=12) under intensive insulin treatment.

Aim:

To assess the effect of mixed meal composition on postprandial glycemic control, in subjects with type 1 diabetes:

  1. Combined effect of proteins and fats
  2. Effect of alcohol consumption

Methods:

Each subject will undergo three mixed meal test studies (on three different days), with identical CHO content: On one occasion a low fat-low protein meal will be given, and on another a high fat-high protein one, both consumed with a non-alcoholic drink; on a third occasion the same high fat-high protein meal will be consumed, but this time accompanied by an equal volume of an alcoholic drink.

Patients will arrive at the research unit at 8:00 am and their blood glucose will be stabilized around 90 mg/dl before each mixed meal test. After the mixed meal, blood will be drawn every 5-30 min during a 6 hour post-prandial period to assess plasma glucose, hormones and metabolites concentration.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia
      • Gandia, Valencia, Spain, 46072
        • Hospital Francesc de Borja

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with type 1 diabetes mellitus for more than one year, aged between 18 and 60 years; on intensive insulin therapy by means of CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for at least 6 months before screening; glycosylated haemoglobin of 6-8.5%; without severe chronic micro- and macroangiopathic diabetic complications and with a body mass index (BMI) between 18 and 30 kg/m2.

Exclusion Criteria:

  • Pregnancy and lactation
  • Hypoglycemia unawareness
  • Fatal or progressive disease
  • Drugs or alcohol abuse
  • HIV, active hepatitis B, active hepatitis C
  • Hepatic disease (aminotransferases AST or ALT >2 times above normal)
  • Clinically relevant microangiopathic disease, or other diseases that may interfere with participation in the study or data analysis
  • Pre-planned surgery
  • Blood donation in the previous 3 months for men and 6 months for women
  • Mental conditions that may interfere with the subject's comprehension of the aims and possible consequences of the study
  • Non-compliant subjects
  • Use of experimental medications or devices during the previous 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low Protein-Low Fat study
Subjects will receive a mixed meal with carbohydrates (70g) plus a low content of proteins and fats
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
Experimental: High Protein-High Fat study
Subjects will receive a mixed meal with the same carbohydrates content of arm 1 (70g), but a greater amount of fats and proteins
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
Experimental: High Protein-High Fat & alcohol study
Subjects will receive the same mixed meal of the High Protein-High Fat study plus 0,7g of alcohol per Kg of weight
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Glucose
Time Frame: 6 hours (plasma glucose will be measured every 5-15 minutes during the 6-hour post-prandial period of each mixed meal test).
Post-prandial plasma glucose time series
6 hours (plasma glucose will be measured every 5-15 minutes during the 6-hour post-prandial period of each mixed meal test).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC-PG
Time Frame: AUC of plasma glucose will be calculated for the whole 6 hour post-prandial period, for the early 0-3 hour post-prandial period and for the late 3-6 hour post-prandial period.
Area Under the Curve (AUC) of Plasma Glucose in the 0-6h, 0-3h and 3-6h post-prandial periods
AUC of plasma glucose will be calculated for the whole 6 hour post-prandial period, for the early 0-3 hour post-prandial period and for the late 3-6 hour post-prandial period.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range
Time Frame: 6 hours (time in range during the 6 hour post-prandial period)
Time in acceptable glucose range (70-180 mg/dl)
6 hours (time in range during the 6 hour post-prandial period)
C Max
Time Frame: 6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period)
Maximum of plasma glucose concentration
6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period)
T max
Time Frame: 6 hours (Time of maximum plasma glucose concentration during the 6 hour post-prandial period)
Time of Maximum plasma glucose concentration
6 hours (Time of maximum plasma glucose concentration during the 6 hour post-prandial period)
Hormones and metabolites
Time Frame: 6 hours (plasma hormones and metabolites will be measured every 30 minutes during the 6-hour post-prandial period)
Plasma concentration of free fatty acids, beta-OH-butyrate, lactate, alanine, counterregulatory hormones
6 hours (plasma hormones and metabolites will be measured every 30 minutes during the 6-hour post-prandial period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jorge Bondia

Collaborators

Ministerio de Economía y Competitividad, Spain
Hospital Francesc de Borja, Gandia, Spain

Investigators

  • Principal Investigator: Paolo Rossetti, PhD, Hospital Francesc de Borja, Gandia
  • Study Director: Jorge Bondia Company, PhD, Universitat Politècnica de València

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2018

Primary Completion (Actual)

January 23, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 20, 2017

First Posted (Actual)

October 25, 2017

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPI2016-78831-C2-1-R_alcohol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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