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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128089

Locations
United States, Virginia
Manassas Internal Medicine
Manassas, Virginia, United States, 20110
Sponsors and Collaborators
Manassas Internal Medicine
Investigators
Principal Investigator: John F Cary, MD Manassas Internal Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00128089     History of Changes
Other Study ID Numbers: 2005-1
Study First Received: August 8, 2005
Last Updated: December 20, 2005
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013