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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
Manassas Internal Medicine
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 8, 2005
Last Updated
December 20, 2005
Sponsor
Manassas Internal Medicine
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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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