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

This study has been completed.
Sponsor:
Information provided by:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00371800
First received: August 31, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371800

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

No publications provided

ClinicalTrials.gov Identifier: NCT00371800     History of Changes
Other Study ID Numbers: 17648
Study First Received: August 31, 2006
Last Updated: August 31, 2006
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014