How to be Safe With Alcoholic Drinks in Diabetes

NCT02518022 | Withdrawn

• 1 other identifier: BEER2015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus; Hypoglycemia

Keywords

Type 1 Diabetes mellitus; Hypoglycemia; continuous subcutaneous insulin infusion; Alcohol; continuous glucose monitoring system; Nutrition

Outcome Measures

Primary Outcomes (1)

• • Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am)

  18 hours

Secondary Outcomes (8)

• • Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day

  18 hours

• • Total Area under the curve

  18 hours

• • average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day

  18 hours

• • Time from end of consumption to nadir of serum glucose

• • Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch

  18 hours

Study Arms (2)

Intervention

EXPERIMENTAL

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

Standard

NO INTERVENTION

No Insulin Treatment of carbohydrates in beer.

Interventions

Insulin DRUG

Insulin for beer

Also known as: Novorapid or Humalog

Intervention

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kinderkrankenhaus auf der Bult: lead
• Hannover Medical School: collaborator

Study Sites (1)

Kinder - und Jugendkrankenhaus AUF DER BULT

Hanover, 30173, Germany

Location

Related Publications (6)

• Krebs HA, Freedland RA, Hems R, Stubbs M. Inhibition of hepatic gluconeogenesis by ethanol. Biochem J. 1969 Mar;112(1):117-24. doi: 10.1042/bj1120117.

  PMID: 5774487 BACKGROUND

• 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. doi: 10.2337/diacare.24.11.1888.

  PMID: 11679452 BACKGROUND

• 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. doi: 10.2337/diacare.15.4.546.

  PMID: 1499475 BACKGROUND

• 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

  BACKGROUND

• 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. doi: 10.2337/diacare.16.12.1612.

  PMID: 8299457 BACKGROUND

• 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. doi: 10.1007/s004140000154.

  PMID: 11197633 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Insulin; Insulin Aspart; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Torben Biester, MD

  Study Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: August 7, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 4, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)