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CompletedNCT00729079DPPUpdated Oct 12, 2015

Diabetes Prevention Program Pilot Study

An interventional study of DPP and DPP in Diabetes Prevention, sponsored by University of Rochester. Completed at 2 sites in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-12.

Sponsored by University of Rochester · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study 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).

02

Conditions studied

  • Diabetes Prevention

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Keywords

  • Diabetes Prevention
  • Pre-Diabetes
  • Exercise
  • Fat Intake
  • Fasting blood sugar
  • tobacco cessation
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In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 36 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age >18 years
  • BMI >24 kg/m2 (>22 kg/m2 among Asian Americans)
  • IGT (2-h plasma glucose 140\~199 mg/dl based on 75-g OGTT if available). The OGTT will not be required for inclusion, but the CMA practitioners may wish to recommend the OGTT for their patients.
  • Elevated FPG (95\~125 mg/dl*).
  • HDL-triglyceride ration > 3.5.

Exclusion criteria

Exclusion Criteria:

  • Diabetes at baseline
  • FPG >126 mg/dl*
  • 2-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)
  • Recent or significant abdominal surgery
  • Pulmonary disease with dependence on oxygen or daily use of bronchodilators
  • Chronic infection (e.g., HIV, active tuberculosis)
  • Conditions or behaviors likely to affect conduct of the trial
  • Unable to communicate with clinic staff (e.g., read and speak English).
  • Unwilling to accept treatment assignment by randomization
  • Participation in another intervention research project that might interfere with DPP
  • Weight loss of > 10% in past 6 months for any reason except postpartum weight loss
  • Unable to walk 0.25 miles in 10 min
  • Currently pregnant or within 3 months postpartum
  • Currently nursing or within 6 weeks of having completed nursing
  • Pregnancy anticipated during the course of the trial
  • Unwilling to undergo pregnancy testing or report possible pregnancy promptly
  • Unwilling to take adequate contraceptive measures, if potentially fertile
  • Major psychiatric disorder, including severe active major depression, severe anxiety, schizophrenia, manic depression, bi-polar disorder
  • Excessive alcohol intake, either acute or chronic
  • Medications and medical conditions likely to confound the assessment for diabetes including:

    • Niacin, in doses indicated for lowering serum triglycerides
    • Glucocorticoids, systemic
  • Other prescription weight-loss medications
  • Active Thyroid disease, suboptimally treated as indicated by abnormal serum thyroid-stimulating hormone
  • Other endocrine disorders (e.g., Cushing's syndrome, acromegaly)
  • Fasting plasma triglyceride >600 mg/dl, despite treatment
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    1

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

    Behavioral: DPP

  • Active comparator
    2

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

    Behavioral: DPP

Interventions

  • BehavioralDPP

    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

  • BehavioralDPP

    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

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What researchers measure

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

  2. ;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

    Time frame: 6 months

07

Study locations

2 sites
  • Clinton Medical Associated
    Rochester, New York 14620, United States
  • Therapeutic Lifestyle Changes
    Rochester, New York 14620, United States
08

References and documents

Publications

  • 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. PubMed 18165335 ↗
  • 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. PubMed 12610015 ↗
  • 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. PubMed 15275675 ↗
  • 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. PubMed 15738451 ↗
  • 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. PubMed 16777547 ↗
  • 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. PubMed 11333990 ↗
  • 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. PubMed 17244837 ↗
  • 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. PubMed 8558405 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00729079
Lead sponsor
University of Rochester
Responsible party
Geoffrey Williams (Professor, University of Rochester) — Principal investigator
First posted
Aug 6, 2008
Start date
Dec 2008
Primary completion
Jul 2009
Completion
Oct 2009
Last update
Oct 12, 2015

Study contacts

Geoffrey C Williams, MD, PhD
principal investigator · University ofRochester
Heather Patrick, PhD
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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