Status:
COMPLETED
Impact of Meal Composition and Alcohol Consumption on Postprandial Glycemic Control in Subjects With Type 1 Diabetes
Lead Sponsor:
Jorge Bondia
Collaborating Sponsors:
Hospital Francesc de Borja, Gandia, Spain
Ministerio de Economía y Competitividad, Spain
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-60 years
Phase:
NA
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 subjec...
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03320993
Start Date
October 25 2018
End Date
January 31 2020
Last Update
March 9 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Francesc de Borja
Gandia, Valencia, Spain, 46072