The Effect of Cinnamon on HbA1c Among Adolescents With Type I Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

The Effect of Cinnamon on HbA1c Among Adolescents With Type I Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371800
• Other study ID #: 17648
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 31, 2006
• Last updated: August 31, 2006
• Start date: October 2005
• Est. completion date: May 2006

Study information

• Verified date: August 2006
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

the purpose of this study is to determine if cinnamon improves glucose control among adolescents with type 1 diabetes mellitus.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of Type 1 diabetes for > 18 months prior to enrollment,

2. Age 13-18 years at the time of enrollment

3. Presenting to the clinic for routine care,

4. No hospital admissions for medical or psychiatric reasons in the 12 months prior to enrollment,

5. Accessible by phone,

6. Not pregnant.

Exclusion Criteria:

(1) Pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• cinnamon

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c
Secondary	Total Daily Insulin
Secondary	Carbohydrate/insulin dose
Secondary	Hypoglycemic events
Secondary	Compliance