Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00276939
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2006-01-11
Brief Title:
Plant-Based Dietary Intervention in Type 2 Diabetes
Sponsor:
Physicians Committee for Responsible Medicine
Organization:
Physicians Committee for Responsible Medicine
Study Overview
Official Title:
Plant-Based Dietary Intervention in Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2012-08
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:
The purpose of the study is to assess whether in individuals with type 2 diabetes a low-fat vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association ADA guidelines The principal measure is hemoglobin A1c Cardiovascular risk factors and dietary acceptability are also assessed The study duration is 22 weeks with a one-year follow-up
Detailed Description:
Preliminary evidence suggests that low-fat vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes as demonstrated by reductions in fasting serum glucose concentrations and medication use We therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period The principal dependent measure is hemoglobin A1c Cardiovascular risk factors are also being tracked as is dietary acceptance
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