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NCT Number: NCT03320993

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

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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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Francesc de Borja

Gandia, Valencia, 46072, Spain

About this study

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:

  • Combined effect of proteins and fats
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mixed meal with different macronutrient composition

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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)

  2. C Max

    Time frame: 6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period)

    Maximum of plasma glucose concentration

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Jorge Bondia

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2017
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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