The Effect of Cinnamon on HbA1c Among Adolescents With Type I Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cinnamon
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Cinnamon, Type 1 Diabetes, Adolescent, HbA1c
Eligibility Criteria
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
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
Total Daily Insulin
Carbohydrate/insulin dose
Hypoglycemic events
Compliance
Full Information
NCT ID
NCT00371800
First Posted
August 31, 2006
Last Updated
August 31, 2006
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Dartmouth College
1. Study Identification
Unique Protocol Identification Number
NCT00371800
Brief Title
The Effect of Cinnamon on HbA1c Among Adolescents With Type I Diabetes
Official Title
The Effect of Cinnamon on HbA1c Among Adolescents With Type I Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Dartmouth College
4. Oversight
5. Study Description
Brief Summary
the purpose of this study is to determine if cinnamon improves glucose control among adolescents with type 1 diabetes mellitus.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Cinnamon, Type 1 Diabetes, Adolescent, HbA1c
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cinnamon
Primary Outcome Measure Information:
Title
HbA1c
Secondary Outcome Measure Information:
Title
Total Daily Insulin
Title
Carbohydrate/insulin dose
Title
Hypoglycemic events
Title
Compliance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel J Casella, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
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The Effect of Cinnamon on HbA1c Among Adolescents With Type I Diabetes
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