NCT00793741

Brief Summary

The purpose of this study is to determine whether islet transplantation alters brain glucose concentrations in patients with type 1 diabetes, recurrent hypoglycemia, and hypoglycemia unawareness when compared to that measured prior to transplant in the same subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

9.3 years

First QC Date

November 18, 2008

Last Update Submit

January 16, 2018

Conditions

Type 1 DiabetesHypoglycemia Unawareness

Keywords

Type 1 diabetesHypoglycemia unawarenessIslet transplant

Outcome Measures

Primary Outcomes (1)

  • Brain glucose concentration as measured by NMR spectroscopy

    5 years

Study Arms (2)

1

Type 1 Diabetes Hypoglycemia unawareness Islet transplant candidate

Drug: somatostatin

2

Healthy control subjects

Drug: somatostatin

Interventions

somatostatinDRUG

Somatostatin may be used to suppress endogenous insulin secretion

12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Endocrinology clinic, community

You may qualify if:

  • Age 18-65
  • Must be able to provide informed consent
  • Type 1 diabetes \>5 years duration
  • Healthy controls

You may not qualify if:

  • Over 300 pounds
  • Claustrophobic
  • History of ischemic heart disease, arrhythmia or seizure disorder
  • Pregnant
  • On medications known to alter blood flow or carbohydrate metabolism
  • Have internally located pieces of metal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPancreatic HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Elizabeth R Seaquist, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2008

First Posted

November 19, 2008

Study Start

December 1, 2007

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(1)