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How to be Safe With Alcoholic Drinks in Diabetes (BEER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518022
Recruitment Status : Withdrawn (unexpected low willingness of patient to participate on the study)
First Posted : August 7, 2015
Last Update Posted : August 4, 2016
Sponsor:
Collaborator:
Hannover Medical School
Information provided by (Responsible Party):
Kinderkrankenhaus auf der Bult

Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Hypoglycemia Drug: Insulin Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: Intervention
For carbohydrates in beer, subjects will get covering by Insulin (1/2 of calculated amount). As well Insulin basal rate will set to half for 12 hours
Drug: Insulin
Insulin for beer
Other Name: Novorapid or Humalog

No Intervention: Standard
No Insulin Treatment of carbohydrates in beer.



Primary Outcome Measures :
  1. • Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am) [ Time Frame: 18 hours ]

Secondary Outcome Measures :
  1. • Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day [ Time Frame: 18 hours ]
  2. • Total Area under the curve [ Time Frame: 18 hours ]
  3. • average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day [ Time Frame: 18 hours ]
  4. • Time from end of consumption to nadir of serum glucose
  5. • Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch [ Time Frame: 18 hours ]
  6. • Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch [ Time Frame: 18 hours ]
  7. • Time in Hypoglycaemia <70 mg/dl per treatment arm [ Time Frame: 18 hours ]
  8. • Max. alcohol in expiratory breath [ Time Frame: 3 hours ]


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Ages Eligible for Study:   16 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518022


Locations
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Germany
Kinder - und Jugendkrankenhaus AUF DER BULT
Hannover, Germany, 30173
Sponsors and Collaborators
Kinderkrankenhaus auf der Bult
Hannover Medical School
Investigators
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Principal Investigator: Torben Biester, MD Study Physician
Publications:
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Responsible Party: Kinderkrankenhaus auf der Bult
ClinicalTrials.gov Identifier: NCT02518022    
Other Study ID Numbers: BEER2015
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kinderkrankenhaus auf der Bult:
Type 1 Diabetes mellitus
Hypoglycemia
continuous subcutaneous insulin infusion
Alcohol
continuous glucose monitoring system
Nutrition
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin Lispro
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs