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

Study Overview
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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.

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: 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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Other: Mixed meal with different macronutrient composition


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 3-period, 3-treatment crossover design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Protein-Low Fat study<br>Subjects will receive a mixed meal with carbohydrates (70g) plus a low content of proteins and fats | Other: Mixed meal with different macronutrient composition<br>* A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given<br>|
| Experimental: High Protein-High Fat study<br>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<br>* A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given<br>|
| Experimental: High Protein-High Fat & alcohol study<br>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<br>* A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Glucose | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-prandial glucose control, alcohol