Trial of New Dietary Treatment of Diabetes

December 20, 2005 updated by: Manassas Internal Medicine

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Manassas Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Glycated hemoglobin (A1C) changes
Weight (body mass index [BMI]) loss
Diabetes medication reduction

Secondary Outcome Measures

Outcome Measure
Patient satisfaction
Hypoglycemia
Other medication reduction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manassas Internal Medicine

Investigators

  • Principal Investigator: John F Cary, MD, Manassas Internal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (ESTIMATE)

August 9, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 21, 2005

Last Update Submitted That Met QC Criteria

December 20, 2005

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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