Trial of New Dietary Treatment of Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dietary treatment
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Obesity, Dietary treatment, Fasting as medical therapy
Eligibility 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
Sites / Locations
- Manassas Internal Medicine
Outcomes
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
Full Information
NCT ID
NCT00128089
First Posted
August 8, 2005
Last Updated
December 20, 2005
Sponsor
Manassas Internal Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00128089
Brief Title
Trial of New Dietary Treatment of Diabetes
Official Title
Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Terminated
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Manassas Internal Medicine
4. Oversight
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Obesity, Dietary treatment, Fasting as medical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Dietary treatment
Primary Outcome Measure Information:
Title
Glycated hemoglobin (A1C) changes
Title
Weight (body mass index [BMI]) loss
Title
Diabetes medication reduction
Secondary Outcome Measure Information:
Title
Hypoglycemia
Title
Other medication reduction
Title
Patient satisfaction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F Cary, MD
Organizational Affiliation
Manassas Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manassas Internal Medicine
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of New Dietary Treatment of Diabetes
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