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

August 31, 2006 updated by: Dartmouth-Hitchcock Medical Center
the purpose of this study is to determine if cinnamon improves glucose control among adolescents with type 1 diabetes mellitus.

Study Overview

Status

Completed

Intervention / Treatment

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

Interventional

Enrollment

72

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Samuel J Casella, MD, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

August 31, 2006

First Submitted That Met QC Criteria

August 31, 2006

First Posted (ESTIMATE)

September 4, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 4, 2006

Last Update Submitted That Met QC Criteria

August 31, 2006

Last Verified

August 1, 2006

More Information

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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