Trial of New Dietary Treatment of Diabetes
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes|
- Glycated hemoglobin (A1C) changes
- Weight (body mass index [BMI]) loss
- Diabetes medication reduction
- Other medication reduction
- Patient satisfaction
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||December 2005|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128089
|United States, Virginia|
|Manassas Internal Medicine|
|Manassas, Virginia, United States, 20110|
|Principal Investigator:||John F Cary, MD||Manassas Internal Medicine|