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Epigenetic Modifications of Diabetes Mellitus Type I

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01623388
First Posted: June 20, 2012
Last Update Posted: January 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
  Purpose
This research is being done to find out if significant changes in blood glucose cause bad outcomes in patients with diabetes.

Condition Intervention
Type I Diabetes Procedure: Oral glucose tolerance test for Phase I

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Epigenetic Modifications Induced by Glycemic Variability

Resource links provided by NLM:


Further study details as provided by Eric Topol, MD, Scripps Translational Science Institute:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
Whole blood

Enrollment: 0
Study Start Date: January 2013
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Phase I Procedure: Oral glucose tolerance test for Phase I
Oral glucose tolerance test for Diabetic patients in phase I

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Type I Diabetic
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623388


Locations
United States, California
Scripps
San Diego, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
  More Information

Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01623388     History of Changes
Other Study ID Numbers: 11-5649
First Submitted: June 7, 2012
First Posted: June 20, 2012
Last Update Posted: January 9, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases