NCT01623388

Brief Summary

This research is being done to find out if significant changes in blood glucose cause bad outcomes in patients with diabetes.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

June 7, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

June 7, 2012

Last Update Submit

January 7, 2014

Conditions

Type I Diabetes

Outcome Measures

Primary Outcomes (1)

  • Evaluate blood sugar variability in Type I diabetics for differences in epigenetic signatures between Type I diabetics with little glycemic variability as compared to those with more pronounced glycemic changes.

    7 days

Study Arms (1)

Phase I

Procedure: Oral glucose tolerance test for Phase I

Interventions

Oral glucose tolerance test for Phase IPROCEDURE

Oral glucose tolerance test for Diabetic patients in phase I

Phase I

Eligibility Criteria

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

Type I Diabetic

You may qualify if:

  • years old
  • Diagnosis of Type I diabetes
  • Willing to wear continuous blood glucose monitor as specified in protocol

You may not qualify if:

  • Pregnant or planning to become pregnant during the study
  • years old
  • Willing to wear continuous blood glucose monitor as specified in protocol
  • Pregnant or planning to become pregnant during the study
  • Diagnosis of Type I or II Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps

San Diego, California, 92037, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucose Tolerance TestClinical Trials, Phase I as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative TechniquesClinical Trials as TopicClinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 20, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

US(1)