Diabetes Prevention Program Pilot Study - Full Text View

Sponsored by:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00729079

Purpose

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).

Condition	Intervention
Diabetes Prevention	Behavioral: DPP

MedlinePlus related topics: Diabetes Exercise and Physical Fitness Weight Control

Drug Information available for: Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	Virtual Translation of Diabetes Prevention to Primary Care: A Pilot Study

Further study details as provided by University of Rochester:

Primary Outcome Measures:

The primary outcome measure is weight loss with a goal of 7% of initial weight. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
;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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Subject will be randomly assigned to work with providers at Clinton Medical Associates	Behavioral: DPP The primary outcome measure is weight loss with a goal of 7% of initial weight. Secondary outcomes are adherence to behavior changes: Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week 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
2: Active Comparator Subjects will be randomly assigned to work with providers at 1655 Elmwood AVe, Suite 125	Behavioral: DPP The primary outcome measure is weight loss with a goal of 7% of initial weight. Secondary outcomes are adherence to behavior changes: Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week 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

Arms

Assigned Interventions

1: Active Comparator

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

Behavioral: DPP

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

2: Active Comparator

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

Behavioral: DPP

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

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729079

Contacts

Contact: Laurie S Passalacqua, MS	5855302050	Laurie_Passalacqua@urmc.rochester.edu
Contact: Heather Patrick, PhD	5855302050	Heather_Patrick@urmc.rochester.edu

Locations

United States, New York
Therapeutic Lifestyle Changes
Rochester, New York, United States, 14620
Clinton Medical Associated
Rochester, New York, United States, 14620

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:	Geoffrey C Williams, MD, PhD	University ofRochester
Principal Investigator:	Heather Patrick, PhD	University of Rochester

More Information

Diabetes Prevention Program This link exits the ClinicalTrials.gov site

Publications:

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

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.

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. Review.

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.

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. Review.

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.

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

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.

Responsible Party:	University of Rochester ( Geoffrey C Williams, MD PhD )
Study ID Numbers:	24895
Study First Received:	August 1, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00729079
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Diabetes Prevention
Pre-Diabetes
Exercise

Fat Intake
Fasting blood sugar
tobacco cessation

Study placed in the following topic categories:

Metabolic Diseases
Glucose Intolerance
Benzocaine
Prediabetic State
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 13, 2009