Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445354
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2007-03-07
Brief Title:
Randomized Controlled Clinical Trial of Cinnamon to Lower Hemoglobin A1c
Sponsor:
Eglin AFB Regional Hospital
Organization:
Eglin AFB Regional Hospital
Study Overview
Official Title:
A Randomized Controlled Clinical Trial Comparing the Effect of 1g of Daily Cinnamon Plus Usual Care to Usual Cre on the Hemoglobin A1c of Uncontrolled Type 2 Diabetics
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will randomize diabetics with hemoglobin A1c greater than 70 to receive either cinnamon plus usual care or usual care alone Hemoglobin A1c will be measured at intake and after 90 days
Detailed Description:
As the worldwide incidence of diabetes increases the search for dietary adjuncts to treat this life-altering disease becomes far ranging Cinnamon is purported to be a natural insulin sensitizer without any known adverse events Both in vitro and in vivo animal studies have shown that cinnamon is an insulin sensitizer1 Several compounds within cinnamon have been identified as possible sources of this sensitization process
To-date three small randomized trials studying cinnamon in human diabetics have been published Khan et al reported that fasting serum glucose could be reduced by 18-29 after 40 days of supplementation with 1 3 or 6 g of cinnamon Cinnamomum cassia in type 2 diabetics 2 This study had several limitations that included failure to measure hemoglobin A1C all patients were Pakistani and no power analysis was documented Vanschoonbeek et al3 report a small RCT of postmenopausal women with well-controlled type 2 diabetes which showed no change in HbA1C or fasting glucose Once again no power analysis is reported Mang et al 4 conducted a RCT of type 2 diabetics treated with aqueous extract of cinnamon for 4 months They report a 15 decrease in fasting glucose and no change in HbA1C over the duration of this trial Subjects had HbA1C less than 7 and again no power analysis was included in this study
This study will address whether cinnamon at the dose of 1g daily in addition to usual care lowers hemoglobin A1c compared to usual care Power analysis indicates that 63 per group are needed and we will recruit 70 patients
To-date three small randomized trials studying cinnamon in human diabetics have been published Khan et al reported that fasting serum glucose could be reduced by 18-29 after 40 days of supplementation with 1 3 or 6 g of cinnamon Cinnamomum cassia in type 2 diabetics 2 This study had several limitations that included failure to measure hemoglobin A1C all patients were Pakistani and no power analysis was documented Vanschoonbeek et al3 report a small RCT of postmenopausal women with well-controlled type 2 diabetes which showed no change in HbA1C or fasting glucose Once again no power analysis is reported Mang et al 4 conducted a RCT of type 2 diabetics treated with aqueous extract of cinnamon for 4 months They report a 15 decrease in fasting glucose and no change in HbA1C over the duration of this trial Subjects had HbA1C less than 7 and again no power analysis was included in this study
This study will address whether cinnamon at the dose of 1g daily in addition to usual care lowers hemoglobin A1c compared to usual care Power analysis indicates that 63 per group are needed and we will recruit 70 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None