Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
10 participants
INTERVENTIONAL
2005-08-31
2005-12-31
Brief Summary
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Study terminated December 19, 2005 for administrative reasons.
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Dietary treatment
Eligibility Criteria
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Inclusion Criteria
* Obesity
* Ability to attend office visits in Manassas, Virginia
Exclusion Criteria
* Institutionalized living
* Retinopathy, neuropathy
* Pregnancy
* Serious health problems such as heart disease or stroke
18 Years
70 Years
ALL
No
Sponsors
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Manassas Internal Medicine
OTHER
Principal Investigators
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John F Cary, MD
Role: PRINCIPAL_INVESTIGATOR
Manassas Internal Medicine
Locations
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Manassas Internal Medicine
Manassas, Virginia, United States
Countries
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Other Identifiers
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2005-1
Identifier Type: -
Identifier Source: org_study_id