How to be Safe With Alcoholic Drinks in Diabetes

Type 1 Diabetes Mellitus Clinical Trial

— BEER  

Official title:

A Monocentric, Controlled, Randomized, Open-label Cross-over Study to Explore the Possible Insulin Treatment of Beverages Containing Alcohol and Carbohydrates in Adolescents and Young Adults With Type 1 Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02518022
• Other study ID #: BEER2015
• Status: Withdrawn
• Phase: N/A
• First received: May 22, 2015
• Last updated: August 3, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Kinderkrankenhaus auf der Bult
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to show that during and after drinking beer a treatment strategy by insulin bolus and reduction of basal rate reduces the rate of hyperglycaemia without an increase of hypoglycaemic events compared to a treatment strategy according to the standard recommendation without insulin Bolus.

Description:

Participants will get two times a height, weight an gender based amount of beer.

One time (Standard) there will be no Insulin given for the beer. Second time (Intervention) half of the carbohydrates containing in the beer will be covered with Insulin, additionally the basal rate will be set to 50% for 12 hours.

All the time, Glucose will be monitored by continuous subcutaneous Glucose Monitoring.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 21 Years

Eligibility

Inclusion Criteria:

• Signed informed consent by participants

• Signed informed consent by parent or legal guardian of adolescent participants <18 years of age

• Age between16-21 years (both including)

• >1 year Type 1 Diabetes

• continuous subcutaneous insulin infusion for at least 3 months

• HbA1c 7-10 % (both including)

• BMI between10-95th percentile for gender and age (both including) for adolescents, <95th percentile for adults

• Ability to wear glucose sensor

• Normal liver enzymes (alanine aminotransferase , aspartate transaminase , Gamma-Glutamyl-Transferase, bilirubin) in age appropriate range by local lab

Exclusion Criteria:

• Severe hypoglycaemia or diabetic ketoacidosis in the past 6 month

• Alcohol or drug abuse

• Psychiatric disorder

• Unstable other metabolic disease as judged by investigator

• Intake of glucocorticoids or growth hormone

• Allergy to adhesive

• Coeliac disease

• Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Insulin
Insulin for beer

Locations

Country	Name	City	State
Germany	Kinder - und Jugendkrankenhaus AUF DER BULT	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Kinderkrankenhaus auf der Bult	Hannover Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Gin H, Morlat P, Ragnaud JM, Aubertin J. Short-term effect of red wine (consumed during meals) on insulin requirement and glucose tolerance in diabetic patients. Diabetes Care. 1992 Apr;15(4):546-8. — View Citation

Jennifer F. Scheel, Karin Schielke, Stefan Lautenbacher, Sabine Aust1, Simone Kremer, Jörg Wolstein; Low-Dose Alcohol Effects on Attention in Adolescents, Zeitschrift für Neuropsychologie, 24 (2), 2013, 103 - 111

Koivisto VA, Tulokas S, Toivonen M, Haapa E, Pelkonen R. Alcohol with a meal has no adverse effects on postprandial glucose homeostasis in diabetic patients. Diabetes Care. 1993 Dec;16(12):1612-4. — View Citation

Krebs HA, Freedland RA, Hems R, Stubbs M. Inhibition of hepatic gluconeogenesis by ethanol. Biochem J. 1969 Mar;112(1):117-24. — View Citation

Seidl S, Jensen U, Alt A. The calculation of blood ethanol concentrations in males and females. Int J Legal Med. 2000;114(1-2):71-7. — View Citation

Turner BC, Jenkins E, Kerr D, Sherwin RS, Cavan DA. The effect of evening alcohol consumption on next-morning glucose control in type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1888-93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am)		18 hours	Yes
Secondary	• Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day		18 hours	Yes
Secondary	• Total Area under the curve		18 hours	No
Secondary	• average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day		18 hours	No
Secondary	• Time from end of consumption to nadir of serum glucose		unknown	No
Secondary	• Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch		18 hours	No
Secondary	• Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch		18 hours	No
Secondary	• Time in Hypoglycaemia <70 mg/dl per treatment arm		18 hours	No
Secondary	• Max. alcohol in expiratory breath		3 hours	No