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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371800
First Posted: September 4, 2006
Last Update Posted: September 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dartmouth College
Information provided by:
Dartmouth-Hitchcock Medical Center
  Purpose
the purpose of this study is to determine if cinnamon improves glucose control among adolescents with type 1 diabetes mellitus.

Condition Intervention Phase
Type 1 Diabetes Mellitus Drug: cinnamon Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Cinnamon on HbA1c Among Adolescents With Type I Diabetes

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • HbA1c

Secondary Outcome Measures:
  • Total Daily Insulin
  • Carbohydrate/insulin dose
  • Hypoglycemic events
  • Compliance

Estimated Enrollment: 72
Study Start Date: October 2005
Estimated Study Completion Date: May 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371800


Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Dartmouth College
Investigators
Principal Investigator: Samuel J Casella, MD Dartmouth-Hitchcock Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00371800     History of Changes
Other Study ID Numbers: 17648
First Submitted: August 31, 2006
First Posted: September 4, 2006
Last Update Posted: September 4, 2006
Last Verified: August 2006

Keywords provided by Dartmouth-Hitchcock Medical Center:
Cinnamon
Type 1 Diabetes
Adolescent
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases