Hypoglycemia | Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
Hypoglycemia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Naltrexone High DoseNaltrexone 100mg for two administrations.
Drug:Naltrexone Low DoseNaltrexone 50mg for two administrations.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Naltrexone (higher dose)Naltrexone 100mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the high dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm.
Naltrexone (lower dose)Naltrexone 50mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the low dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm.
Start Date: August 2011
Completed Date: October 2013
Primary Outcome: Glucose (mg/dL)
Secondary Outcome: Glucagon (pg/mL)
Study sponsors, principal investigator, and references
Principal Investigator: Robert Sherwin, MD
Lead Sponsor: Yale University
Collaborator: National Institutes of Health (NIH)