Epigenetic Modifications of Diabetes Mellitus Type I
This study is not yet open for participant recruitment.
Verified June 2012 by Scripps Translational Science Institute
Sponsor:
Scripps Translational Science Institute
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01623388
First received: June 7, 2012
Last updated: June 19, 2012
Last verified: June 2012
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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:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Dextrose
U.S. FDA Resources
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
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | August 2013 (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 | Not yet recruiting |
| San Diego, California, United States, 92037 | |
| Contact: Sharon Haaser, RN 858-554-5758 haaser.sharon@scrippshealth.org | |
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: | June 19, 2012 |
| 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 May 21, 2013