Trial of New Dietary Treatment of Diabetes
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|ClinicalTrials.gov Identifier: NCT00128089|
Recruitment Status : Terminated
First Posted : August 9, 2005
Last Update Posted : December 21, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Dietary treatment||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes|
|Study Start Date :||August 2005|
|Study Completion Date :||December 2005|
- Glycated hemoglobin (A1C) changes
- Weight (body mass index [BMI]) loss
- Diabetes medication reduction
- Other medication reduction
- Patient satisfaction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128089
|United States, Virginia|
|Manassas Internal Medicine|
|Manassas, Virginia, United States, 20110|
|Principal Investigator:||John F Cary, MD||Manassas Internal Medicine|