NCT00128089

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 21, 2005

Status Verified

December 1, 2005

First QC Date

August 8, 2005

Last Update Submit

December 20, 2005

Conditions

Diabetes Mellitus, Type 2

Keywords

ObesityDietary treatmentFasting as medical therapy

Outcome Measures

Primary Outcomes (3)

  • Glycated hemoglobin (A1C) changes

  • Weight (body mass index [BMI]) loss

  • Diabetes medication reduction

Secondary Outcomes (3)

  • Hypoglycemia

  • Other medication reduction

  • Patient satisfaction

Interventions

Dietary treatmentBEHAVIORAL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus, type 2
  • Obesity
  • Ability to attend office visits in Manassas, Virginia

You may not qualify if:

  • Dementia
  • Institutionalized living
  • Retinopathy, neuropathy
  • Pregnancy
  • Serious health problems such as heart disease or stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manassas Internal Medicine

Manassas, Virginia, 20110, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John F Cary, MD

    Manassas Internal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

August 1, 2005

Study Completion

December 1, 2005

Last Updated

December 21, 2005

Record last verified: 2005-12

Locations

US(1)