NCT01034319

Brief Summary

This study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. Intervention subjects will be provided with their individual diabetes genotype risk score derived from aggregating the combined results of 37 diabetes risk-associated genetic loci. Controls will not be tested. All subjects will be enrolled in a 12-week diabetes prevention program.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

1.7 years

First QC Date

December 16, 2009

Last Update Submit

July 19, 2011

Conditions

Pre-diabetesOverweightMetabolic Syndrome

Keywords

type 2 diabetesgeneticsgenetic counselingdiabetes prevention

Outcome Measures

Primary Outcomes (1)

  • stage of change

    baseline, after counseling, after completing program (3 months)

Secondary Outcomes (1)

  • program attendance

    3 months

Study Arms (2)

Diabetes Genetic Counseling

EXPERIMENTAL

Subjects will have been genotyped and will received genetic counseling based on their results

Behavioral: Diabetes Genetic Counseling

No Genotyping or Counseling

PLACEBO COMPARATOR

Patients will not be genotyped and will therefore not receive genetic counseling

Behavioral: No genetic counseling

Interventions

Diabetes Genetic CounselingBEHAVIORAL

Subjects will be genotyped based on a 37-allele aggregate score and counseled regarding the implications of the results prior to enrollment in a 12-week diabetes prevention program

Diabetes Genetic Counseling
No genetic counselingBEHAVIORAL

These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program

No Genotyping or Counseling

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight (Body mass index ≥ 29.1 kg/m2 in men, ≥ 27.2 kg/m2 in women) with at least 2 other formal criteria for Metabolic Syndrome (see Table -NCEP ATP-III Criteria)
  • Adult (\> 21 years of age)
  • No diagnosis or treatment for diabetes (Type 1 or Type 2) or cardiovascular disease (e.g. myocardial infraction, coronary bypass surgery, congestive heart failure, peripheral vascular disease)
  • Physically able and willing to participate in a 12-week group session curriculum for weight loss and dietary change
  • Able to understand and communicate effectively in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Practice Based Research Network

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Grant RW, O'Brien KE, Waxler JL, Vassy JL, Delahanty LM, Bissett LG, Green RC, Stember KG, Guiducci C, Park ER, Florez JC, Meigs JB. Personalized genetic risk counseling to motivate diabetes prevention: a randomized trial. Diabetes Care. 2013 Jan;36(1):13-9. doi: 10.2337/dc12-0884. Epub 2012 Aug 28.

    PMID: 22933432DERIVED

  • Waxler JL, O'Brien KE, Delahanty LM, Meigs JB, Florez JC, Park ER, Pober BR, Grant RW. Genetic counseling as a tool for type 2 diabetes prevention: a genetic counseling framework for common polygenetic disorders. J Genet Couns. 2012 Oct;21(5):684-91. doi: 10.1007/s10897-012-9486-x.

    PMID: 22302620DERIVED

MeSH Terms

Conditions

Glucose IntoleranceOverweightMetabolic SyndromeDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismDiabetes MellitusEndocrine System Diseases

Study Officials

  • Richard W Grant, MD MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

December 1, 2009

Primary Completion

August 1, 2011

Study Completion

December 1, 2012

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

US(1)