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Trial of New Dietary Treatment of Diabetes

This study has been terminated.
Sponsor:
Information provided by:
Manassas Internal Medicine
ClinicalTrials.gov Identifier:
NCT00128089
First received: August 8, 2005
Last updated: December 20, 2005
Last verified: December 2005

August 8, 2005
December 20, 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 ClinicalTrials.gov Archive Site
  • Hypoglycemia
  • Other medication reduction
  • Patient satisfaction
Same as current
Not Provided
Not Provided
 
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).

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Behavioral: Dietary treatment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00128089
2005-1
Not Provided
Not Provided
Manassas Internal Medicine
Not Provided
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