Epigenetic Modifications of Diabetes Mellitus Type I | NCT01623388

Studies
Epigenetic Modifications of Diabetes Mellitus Type I

NCT01623388

Sponsor

Scripps Translational Science Institute

Status

Withdrawn

Last Update Posted

Jan 9, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Type I Diabetes

Interventions

Oral glucose tolerance test for Phase I

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Not provided

First Submitted Date

Jun 7, 2012

First Submission Date that Met QC Criteria

Jun 19, 2012

First Posted Date

Jun 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2014

Last Update Posted Date

Jan 9, 2014Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase I			Procedure: Oral glucose tolerance test for Phase I

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral glucose tolerance test for Phase I	Procedure	Oral glucose tolerance test for Diabetic patients in phase I	Phase I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-65 years old
Diagnosis of Type I diabetes
Willing to wear continuous blood glucose monitor as specified in protocol

Exclusion Criteria:

Pregnant or planning to become pregnant during the study

Healthy control group Inclusion:

18-65 years old
Willing to wear continuous blood glucose monitor as specified in protocol

Exclusion:

Pregnant or planning to become pregnant during the study
Diagnosis of Type I or II Diabetes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Type I Diabetic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scripps		San Diego	California	92037	United States

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005951	Glucose Tolerance Test
D017321	Clinical Trials, Phase I as Topic

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided