- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00371800
The Effect of Cinnamon on HbA1c Among Adolescents With Type I Diabetes
Study Overview
Detailed Description
Widespread achievement of glucose control remains an elusive goal for adolescents with Type 1 diabetes. Previous research has suggested that cinnamon may be effective at improving glucose control in type 2 diabetes. To date, no research has investigated the effect of cinnamon on type 1 diabetics. If the addition of a simple, natural, pill to a standard insulin regimen can significantly improve glucose control, the clinical implications would be substantial.
Comparison: Using a prospective, double-blind, placebo-controlled design, 72 adolescent type I diabetics were treated with cinnamon (1 gram/day) or an equivalent appearing placebo for 90 days. HbA1c, total daily insulin intake, and adverse events were recorded and compared between groups.
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Type 1 diabetes for > 18 months prior to enrollment,
- Age 13-18 years at the time of enrollment
- Presenting to the clinic for routine care,
- No hospital admissions for medical or psychiatric reasons in the 12 months prior to enrollment,
- Accessible by phone,
- Not pregnant.
Exclusion Criteria:
(1) Pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
HbA1c
|
Secondary Outcome Measures
Outcome Measure |
---|
Compliance
|
Hypoglycemic events
|
Total Daily Insulin
|
Carbohydrate/insulin dose
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Samuel J Casella, MD, Dartmouth-Hitchcock Medical Center
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17648
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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