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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014