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NCT Number: NCT01462227

Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it can also affect the levels of the hormones which are released during hypoglycemia. The aim of this study is to determine whether naltrexone can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.

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Key information

Conditions

Hypoglycemia Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk) age 18-55, BMI 18-35

Exclusion criteria

  • pregnancy
  • significant diabetes complications
  • liver disease, cirrhosis
  • cardiac disease
  • neurological disorder
  • autonomic neuropathy
  • kidney disease
  • lactose intolerance

Treatment and study plan

Naltrexone High Dose

Drug

Naltrexone 100mg for two administrations.

Naltrexone Low Dose

Drug

Naltrexone 50mg for two administrations.

Primary outcomes

  1. Glucose (mg/dL)

    Time frame: End of study (up to 240 minutes)

    Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.

  2. Glucose Infusion Rate (mg/kg.Min)

    Time frame: End of study (up to 240 minutes)

    The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL).

Secondary outcomes

  1. Glucagon (pg/mL)

    Time frame: End of study (up to 240 minutes)

    Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.

  2. Cortisol (ug/dL)

    Time frame: End of study (up to 240 minutes)

    Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.

  3. Epinephrine (pg/mL)

    Time frame: End of study (up to 240 minutes)

    Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.

  4. Norepinephrine (pg/mL)

    Time frame: End of study (up to 240 minutes)

    Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

The Effect of Opiate Blockade With Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 31, 2011
Registry last updated
Feb 18, 2016

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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