Epigenetic Modifications of Diabetes Mellitus Type I

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01623388
First received: June 7, 2012
Last updated: January 7, 2014
Last verified: January 2014
  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 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623388

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

No publications provided

Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01623388     History of Changes
Other Study ID Numbers: 11-5649
Study First Received: June 7, 2012
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014