Trial of New Dietary Treatment of Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128089
Recruitment Status : Terminated
First Posted : August 9, 2005
Last Update Posted : December 21, 2005
Information provided by:
Manassas Internal Medicine

August 8, 2005
August 9, 2005
December 21, 2005
August 2005
Not Provided
  • Glycated hemoglobin (A1C) changes
  • Weight (body mass index [BMI]) loss
  • Diabetes medication reduction
  • A1C Changes
  • Weight (BMI) loss
  • Diabetes medication reduction
Complete list of historical versions of study NCT00128089 on Archive Site
  • Hypoglycemia
  • Other medication reduction
  • Patient satisfaction
Same as current
Not Provided
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Trial of New Dietary Treatment of Diabetes
Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 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.

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).

Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Behavioral: Dietary treatment
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2005
Not Provided

Inclusion Criteria:

  • Diabetes mellitus, type 2
  • Obesity
  • Ability to attend office visits in Manassas, Virginia

Exclusion Criteria:

  • Dementia
  • Institutionalized living
  • Retinopathy, neuropathy
  • Pregnancy
  • Serious health problems such as heart disease or stroke
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Manassas Internal Medicine
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Principal Investigator: John F Cary, MD Manassas Internal Medicine
Manassas Internal Medicine
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP