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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-25

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

3-period, 3-treatment crossover design

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Data analysis will be carried out by a person not involved in the study (she/he will be blind to the study condition)

Study Groups

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Low Protein-Low Fat study

Subjects will receive a mixed meal with carbohydrates (70g) plus a low content of proteins and fats

Group Type ACTIVE_COMPARATOR

Mixed meal with different macronutrient composition

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Mixed meal with different macronutrient composition

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Mixed meal with different macronutrient composition

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No