Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128089
Status:
TERMINATED
Last Update Posted:
2005-12-21
First Post:
2005-08-08
Brief Title:
Trial of New Dietary Treatment of Diabetes
Sponsor:
Manassas Internal Medicine
Organization:
Manassas Internal Medicine
Study Overview
Official Title:
Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes
Status:
TERMINATED
Status Verified Date:
2005-12
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 is a preliminary trial of a new dietary approach to the treatment of obesity related type 2 diabetes
Study terminated December 19 2005 for administrative reasons
Study terminated December 19 2005 for administrative reasons
Detailed Description:
Traditional dietary treatment of type 2 diabetes is complicated and often fails
This is a dietary treatment that uses fingerstick testing of blood sugars and a remarkably simple algorithm to promptly lower the blood glucose to treatment goals
A series of 10 overweight type 2 diabetic patients not well controlled or needing medication for control will be recruited to follow this plan followup is to be until 6 months after the last patient is enrolled or when all patients have normal A1Cs with no medication whichever comes first
Primary endpoints to be measured are A1C weight loss in pounds and BMI reduction and medication reduction Secondary endpoints are occurrences of hypoglycemia reduction of medications for hypertension and hyperlipidemia and patient satisfaction As this is a Phase 1 trial the only control group is historical controls the patients themselves and the medical literature
This is a dietary treatment that uses fingerstick testing of blood sugars and a remarkably simple algorithm to promptly lower the blood glucose to treatment goals
A series of 10 overweight type 2 diabetic patients not well controlled or needing medication for control will be recruited to follow this plan followup is to be until 6 months after the last patient is enrolled or when all patients have normal A1Cs with no medication whichever comes first
Primary endpoints to be measured are A1C weight loss in pounds and BMI reduction and medication reduction Secondary endpoints are occurrences of hypoglycemia reduction of medications for hypertension and hyperlipidemia and patient satisfaction As this is a Phase 1 trial the only control group is historical controls the patients themselves and the medical literature
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