NCT00362193

Brief Summary

This purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P75+ for phase_4 type-2-diabetes

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_4 type-2-diabetes

Status
completed

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

June 1, 2002

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

February 15, 2010

Status Verified

February 1, 2010

First QC Date

August 7, 2006

Last Update Submit

February 12, 2010

Conditions

Type 2 Diabetes

Keywords

DiabetesChronic disease managementRelapse

Outcome Measures

Primary Outcomes (1)

  • Glycemic relapse: increase in HbA1c by 1% over baseline and >8%

Secondary Outcomes (14)

  • Height/Weight

  • Waist/Hip Circumference

  • Systolic/Diastolic BP

  • Demographic variables

  • Duration of Diabetes (years)

  • +9 more secondary outcomes

Interventions

Telephonic diabetes careBEHAVIORAL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Recent control obtain (HbA1c\<8%) after diabetes improvement program
  • Receives care in primary care clinic

You may not qualify if:

  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Huizinga MM, Gebretsadik T, Garcia Ulen C, Shintani AK, Michon SR, Shackleford LO, Wolff KL, Brown AW, Rothman RL, Elasy TA. Preventing glycaemic relapse in recently controlled type 2 diabetes patients: a randomised controlled trial. Diabetologia. 2010 May;53(5):832-9. doi: 10.1007/s00125-010-1658-3. Epub 2010 Jan 19.

    PMID: 20084363DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusRecurrence

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tom A Elasy, MD, MPH

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 7, 2006

First Posted

August 9, 2006

Study Start

June 1, 2002

Study Completion

February 1, 2007

Last Updated

February 15, 2010

Record last verified: 2010-02