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Sponsored by: |
Manassas Internal Medicine |
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Information provided by: | Manassas Internal Medicine |
ClinicalTrials.gov Identifier: | NCT00128089 |
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 | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Behavioral: Dietary treatment |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes |
Estimated Enrollment: | 10 |
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).
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Virginia | |
Manassas Internal Medicine | |
Manassas, Virginia, United States, 20110 |
Principal Investigator: | John F Cary, MD | Manassas Internal Medicine |
Study ID Numbers: | 2005-1 |
Study First Received: | August 8, 2005 |
Last Updated: | December 20, 2005 |
ClinicalTrials.gov Identifier: | NCT00128089 |
Health Authority: | United States: Institutional Review Board |
Obesity Dietary treatment Fasting as medical therapy |
Obesity Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |