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Trial of New Dietary Treatment of Diabetes

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ClinicalTrials.gov Identifier: NCT00128089
Recruitment Status : Terminated
First Posted : August 9, 2005
Last Update Posted : December 21, 2005
Sponsor:
Information provided by:
Manassas Internal Medicine

Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Dietary treatment Phase 1

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).


Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
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
Study Start Date : August 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Hypoglycemia
  2. Other medication reduction
  3. Patient satisfaction


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00128089     History of Changes
Other Study ID Numbers: 2005-1
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: December 21, 2005
Last Verified: December 2005

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