Epigenetic Modifications of Diabetes Mellitus Type I

January 7, 2014 updated by: Eric Topol, MD, Scripps Translational Science Institute

Epigenetic Modifications Induced by Glycemic Variability

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92037
        • Scripps

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type I Diabetic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Phase I
Procedure: Oral glucose tolerance test for Phase I
Oral glucose tolerance test for Diabetic patients in phase I

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (ESTIMATE)

June 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 7, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-5649

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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