NCT00729079

Brief Summary

This pilot study is intended to demonstrate that we can actually deliver the Diabetes Prevention Program intervention well and to show that it is likely effective. We will use results from this pilot study to support our application to The National Institute of Health. NIH is asking for health care centers to show ways to provide this treatment at a reasonable cost. We propose to demonstrate successful and sustainable use DPP's lifestyle intervention in a primary care health care setting (University of Rochester Primary Care).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 12, 2015

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

August 1, 2008

Last Update Submit

October 8, 2015

Conditions

Diabetes Prevention

Keywords

Diabetes PreventionPre-DiabetesExerciseFat IntakeFasting blood sugartobacco cessation

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is weight loss with a goal of 7% of initial weight.

    6 months

Secondary Outcomes (2)

  • Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week

    6 months

  • ;Fat intake less than 25% and saturated fat less than 10% Fiber intake of at least 25 grams per day;Fasting blood sugar < 100 mg/dL; Absence of tobacco use

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Subject will be randomly assigned to work with providers at Clinton Medical Associates

Behavioral: DPP

2

ACTIVE COMPARATOR

Subjects will be randomly assigned to work with providers at 1655 Elmwood AVe, Suite 125

Behavioral: DPP

Interventions

DPPBEHAVIORAL

1. The primary outcome measure is weight loss with a goal of 7% of initial weight. 2. Secondary outcomes are adherence to behavior changes: 1. Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week 2. Fat intake less than 25% and saturated fat less than 10% 3. Fiber intake of at least 25 grams per day 4. Fasting blood sugar \< 100 mg/dL 5. Absence of tobacco use

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • BMI \>24 kg/m2 (\>22 kg/m2 among Asian Americans)
  • Elevated FPG (95\~125 mg/dl\*).
  • HDL-triglyceride ration \> 3.5.

You may not qualify if:

  • Diabetes at baseline
  • FPG \>126 mg/dl\*
  • h plasma glucose \>200 mg/dl based on 75-g OGTT, if available. OGTT will not be required (see above note).
  • Diabetes diagnosed by a physician and confirmed by other clinical data, other than during pregnancy.
  • Ever used antidiabetic medication, other than during pregnancy
  • Medical conditions likely to limit life span and/or increase risk of intervention
  • Cardiovascular disease
  • Hospitalization for treatment of heart disease in past 6 months New York Heart Association Functional Class\> 2
  • Left bundle branch block or third degree AV block Aortic stenosis
  • Systolic blood pressure\> 180 mmHg or diastolic blood pressure\> 105 mmHg
  • Cancer requiring treatment in the past 5 years, unless the prognosis is considered good
  • Renal disease (creatinine GFR \< or = 30 ml/hr or \> 2.0 mg/dl if GFR not available).
  • Anemia (hematocrit \<36% in men or \<33% in women)
  • Hepatitis (based on history or serum transaminase elevation)
  • Other gastrointestinal disease (pancreatitis, acute inflammatory bowel disease)
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinton Medical Associated

Rochester, New York, 14620, United States

Location

Therapeutic Lifestyle Changes

Rochester, New York, 14620, United States

Location

Related Publications (8)

  • American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. No abstract available.

    PMID: 18165335BACKGROUND

  • Benjamin SM, Valdez R, Geiss LS, Rolka DB, Narayan KM. Estimated number of adults with prediabetes in the US in 2000: opportunities for prevention. Diabetes Care. 2003 Mar;26(3):645-9. doi: 10.2337/diacare.26.3.645.

    PMID: 12610015BACKGROUND

  • Goldstein MG, Whitlock EP, DePue J; Planning Committee of the Addressing Multiple Behavioral Risk Factors in Primary Care Project. Multiple behavioral risk factor interventions in primary care. Summary of research evidence. Am J Prev Med. 2004 Aug;27(2 Suppl):61-79. doi: 10.1016/j.amepre.2004.04.023.

    PMID: 15275675BACKGROUND

  • Herman WH, Hoerger TJ, Brandle M, Hicks K, Sorensen S, Zhang P, Hamman RF, Ackermann RT, Engelgau MM, Ratner RE; Diabetes Prevention Program Research Group. The cost-effectiveness of lifestyle modification or metformin in preventing type 2 diabetes in adults with impaired glucose tolerance. Ann Intern Med. 2005 Mar 1;142(5):323-32. doi: 10.7326/0003-4819-142-5-200503010-00007.

    PMID: 15738451BACKGROUND

  • Maciosek MV, Edwards NM, Coffield AB, Flottemesch TJ, Nelson WW, Goodman MJ, Solberg LI. Priorities among effective clinical preventive services: methods. Am J Prev Med. 2006 Jul;31(1):90-6. doi: 10.1016/j.amepre.2006.03.011.

    PMID: 16777547BACKGROUND

  • Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.

    PMID: 11333990BACKGROUND

  • Westfall JM, Mold J, Fagnan L. Practice-based research--"Blue Highways" on the NIH roadmap. JAMA. 2007 Jan 24;297(4):403-6. doi: 10.1001/jama.297.4.403. No abstract available.

    PMID: 17244837BACKGROUND

  • Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.

    PMID: 8558405BACKGROUND

Related Links

MeSH Terms

Conditions

Glucose IntoleranceMotor ActivityTobacco Use Cessation

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehaviorHealth Behavior

Study Officials

  • Geoffrey C Williams, MD, PhD

    University ofRochester

    PRINCIPAL INVESTIGATOR

  • Heather Patrick, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 6, 2008

Study Start

December 1, 2008

Primary Completion

July 1, 2009

Study Completion

October 1, 2009

Last Updated

October 12, 2015

Record last verified: 2013-03

Locations

US(2)