Diabetes Mellitus, Type 1
Conditions
Keywords
post-prandial glucose control, alcohol
Brief 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.
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.
Interventions
OTHERMixed meal with different macronutrient composition
A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given
Sponsors
Hospital Francesc de Borja, Gandia, Spain
Ministerio de Economía y Competitividad, Spain
Jorge Bondia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analysis will be carried out by a person not involved in the study (she/he will be blind to the study condition)
Intervention model description
3-period, 3-treatment crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Glucose | 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
| Measure | Time frame | Description |
|---|---|---|
| AUC-PG | 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
| Measure | Time frame | Description |
|---|---|---|
| Time in range | 6 hours (time in range during the 6 hour post-prandial period) | Time in acceptable glucose range (70-180 mg/dl) |
| C Max | 6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period) | Maximum of plasma glucose concentration |
| T max | 6 hours (Time of maximum plasma glucose concentration during the 6 hour post-prandial period) | Time of Maximum plasma glucose concentration |
| Hormones and metabolites | 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 |
Countries
Spain
Outcome results
None listed