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Trial of New Dietary Treatment of Diabetes

This study has been terminated.
Information provided by:
Manassas Internal Medicine Identifier:
First received: August 8, 2005
Last updated: December 20, 2005
Last verified: December 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 Intervention Phase
Diabetes Mellitus, Type 2 Behavioral: Dietary treatment Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes

Further study details as provided by Manassas Internal Medicine:

Primary Outcome Measures:
  • Glycated hemoglobin (A1C) changes
  • Weight (body mass index [BMI]) loss
  • Diabetes medication reduction

Secondary Outcome Measures:
  • Hypoglycemia
  • Other medication reduction
  • Patient satisfaction

Estimated Enrollment: 10
Study Start Date: August 2005
Estimated Study Completion Date: December 2005
Detailed Description:

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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00128089

United States, Virginia
Manassas Internal Medicine
Manassas, Virginia, United States, 20110
Sponsors and Collaborators
Manassas Internal Medicine
Principal Investigator: John F Cary, MD Manassas Internal Medicine
  More Information Identifier: NCT00128089     History of Changes
Other Study ID Numbers: 2005-1
Study First Received: August 8, 2005
Last Updated: December 20, 2005

Keywords provided by Manassas Internal Medicine:
Dietary treatment
Fasting as medical therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on September 21, 2017