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NCT Number: NCT00160056

The Effect of Antecedent Hypoglycaemia on β2-adrenergic Sensitivity

Hypoglycaemia unawareness is a common complication in patients with type 1 diabetes and with insulin-treated type 2 diabetes of long duration. The loss of autonomic symptoms to hypoglycemia does not solely depend on loss of adrenaline responses.Differences in sensitivity to catecholamines may also be involved.

Reconciling the data on β2-adrenergic receptor polymorphism to those on loss of β-adrenergic sensitivity in diabetic patients with hypoglycemia unawareness, we hypothesize that hypoglycemia unawareness is at least partly the result of desensitization of the β2-adrenergic receptor and that patients who are homozygous for arginine at codon 16 are particularly susceptible for this desensitization process, whereas patients who are homozygous for glycine at codon 16 are resistant for desensitization.

Objectives

1. To determine whether, and if so to what extent, antecedent hypoglycemia reduces β2-adrenergic sensitivity in healthy subjects with Arg16 homozygosity. 2. To investigate whether or not healthy subjects with Gly16 homozygosity are resistant to desensitization 3. To confirm that antecedent hypoglycemia reduces the heart rate response to isoproterenol and to assess to what extent this reduced response is mediated by impairments in baroreflex sensitivity.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Unawareness Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500HB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent
  • Homozygous for Arginine at codon 16 or homozygous Gly at codon 16
  • No regular usage of medication other than oral contraceptives

Exclusion criteria

  • History of cerebrovascular, cardiovascular, or peripheral vascular disease
  • Smoking
  • Alcohol usage of more than 10 units per week
  • Inability to abstain from xanthine-derivatives (coffee, tea, cola, chocolate, cacao) or alcohol for 2 days
  • BMI above 30 kg/m2
  • Participation to any other trial in the preceding 3 months
  • Ongoing disease of any kind
  • Pregnancy

Treatment and study plan

Hypoglycemia

Procedure

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

The Effect of Antecedent Hypoglycaemia on β2-adrenergic Sensitivity in Subjects With Homozygous Arg16 and gly16 Polymorphism of the β2-adrenergic Receptor

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 12, 2005
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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