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NCT01623388 Clinical Trial

Epigenetic Modifications of Diabetes Mellitus Type I

Type I Diabetes Clinical Trial

Official title:
Epigenetic Modifications Induced by Glycemic Variability

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01623388
Other study ID # 11-5649
Secondary ID
Status Withdrawn
Phase N/A
First received June 7, 2012
Last updated January 7, 2014
Start date January 2013

Study information
Verified date January 2014
Source Scripps Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Oral glucose tolerance test for Phase I
Oral glucose tolerance test for Diabetic patients in phase I

Locations
Country Name City State
United States Scripps San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Scripps Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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