NCT01302743

Brief Summary

The purpose of this study is to assess whether Cinnamon bark or water-soluble cinnamon is an effective nutraceutical for the initial treatment of diabetes when compared to standard therapy of Metformin.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 28, 2017

Completed
Last Updated

June 26, 2017

Status Verified

May 1, 2017

Enrollment Period

6.1 years

First QC Date

February 17, 2011

Results QC Date

December 15, 2016

Last Update Submit

May 31, 2017

Conditions

Diabetes

Keywords

DiabetesMetforminCinnamon

Outcome Measures

Primary Outcomes (2)

  • Decrease in HbA1c

    Subjects will have baseline blood levels to measure HbA1c. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.

    90 days

  • Decrease in LDL Cholesterol

    Subjects will have baseline blood levels to measure LDL Cholesterol. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.

    90 days

Study Arms (3)

Metformin

ACTIVE COMPARATOR

oral extended-release Metformin 1000 mg once a day for 90 days

Drug: Group 1: Metformin

Cinnamon Bark

EXPERIMENTAL

Cinnamon Bark 1000 mg once a day for 90 days

Dietary Supplement: Group 2: Cinnamon Bark

Cinnulin PF

EXPERIMENTAL

Cinnulin PF 500 mg once a day for 90 days

Dietary Supplement: Group 3: Cinnulin PF

Interventions

Group 1: MetforminDRUG

Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days

Metformin
Group 2: Cinnamon BarkDIETARY_SUPPLEMENT

Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days

Cinnamon Bark
Group 3: Cinnulin PFDIETARY_SUPPLEMENT

Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.

Cinnulin PF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years or older.
  • Diagnosed with type 2 diabetes mellitus within the past 30 days or who have been diagnosed and have not begun treatment.

You may not qualify if:

  • Subjects who are \<18 yrs of age.
  • Pregnant or breastfeeding.
  • Allergic to cinnamon.
  • Allergic to metformin.
  • Patients taking metformin are excluded from participating, unless they agree to wash out for two weeks prior to entering the study.
  • Patients taking Cinnamon as a dietary supplement are excluded from participating, unless they agree to wash out for two weeks prior to entering the study.
  • Patients taking any of the following:
  • Daily oral steroids
  • Warfarin
  • Hypoglycemic medication
  • Weight loss medication
  • Digoxin, lithium, phenytoin, \& theophylline (due to narrow therapeutic indices)
  • Serum creatinine \>1.5 (this is standard of care that would be measured by PCM upon diagnosis of type 2 diabetes mellitus)
  • Initial hemoglobin A1C \>9.5(this is standard of care that would be measured by PCM upon diagnosis of type 2 diabetes mellitus).
  • Clinical or laboratory evidence of liver disease.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mike O'Callaghan Federal Hospital

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Jill M. Clark, MBA/HCM
Organization
Mike O'Callaghan Federal Medical Center
jill.clark.3.ctr@us.af.mil
702-653-3298

Study Officials

  • Paul Crawford, M.D.

    Mike O'Callaghan Federal Hospital/Nellis Air Force Base

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 24, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 26, 2017

Results First Posted

March 28, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)