NCT00371800

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
Last Updated

September 4, 2006

Status Verified

August 1, 2006

First QC Date

August 31, 2006

Last Update Submit

August 31, 2006

Conditions

Type 1 Diabetes Mellitus

Keywords

CinnamonType 1 DiabetesAdolescentHbA1c

Outcome Measures

Primary Outcomes (1)

  • HbA1c

Secondary Outcomes (4)

  • Total Daily Insulin

  • Carbohydrate/insulin dose

  • Hypoglycemic events

  • Compliance

Interventions

cinnamonDRUG

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • (1) Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Samuel J Casella, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

October 1, 2005

Study Completion

May 1, 2006

Last Updated

September 4, 2006

Record last verified: 2006-08

Locations

US(1)