NCT01462227

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

February 18, 2016

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

October 26, 2011

Results QC Date

January 20, 2016

Last Update Submit

February 17, 2016

Conditions

Hypoglycemia

Keywords

HypoglycemiaType 1 diabetes

Outcome Measures

Primary Outcomes (2)

  • Glucose (mg/dL)

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

    End of study (up to 240 minutes)

  • Glucose Infusion Rate (mg/kg.Min)

    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).

    End of study (up to 240 minutes)

Secondary Outcomes (4)

  • Glucagon (pg/mL)

    End of study (up to 240 minutes)

  • Cortisol (ug/dL)

    End of study (up to 240 minutes)

  • Epinephrine (pg/mL)

    End of study (up to 240 minutes)

  • Norepinephrine (pg/mL)

    End of study (up to 240 minutes)

Study Arms (2)

Naltrexone (higher dose)

EXPERIMENTAL

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.

Drug: Naltrexone High Dose

Naltrexone (lower dose)

EXPERIMENTAL

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.

Drug: Naltrexone Low Dose

Interventions

Naltrexone High DoseDRUG

Naltrexone 100mg for two administrations.

Naltrexone (higher dose)
Naltrexone Low DoseDRUG

Naltrexone 50mg for two administrations.

Naltrexone (lower dose)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

HypoglycemiaDiabetes Mellitus, Type 1

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Robert Stanley Sherwin, MD
Organization
Yale University
robert.sherwin@yale.edu
203 737 1932

Study Officials

  • Robert Sherwin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2011

First Posted

October 31, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

February 18, 2016

Results First Posted

February 18, 2016

Record last verified: 2016-02

Locations

US(1)