Diabetes Prevention Program Pilot Study (DPP)

October 8, 2015 updated by: Geoffrey Williams, University of Rochester

Virtual Translation of Diabetes Prevention to Primary Care: A Pilot Study

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1
Subject will be randomly assigned to work with providers at Clinton Medical Associates
Behavioral: DPP
  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
Active Comparator: 2
Subjects will be randomly assigned to work with providers at 1655 Elmwood AVe, Suite 125
Behavioral: DPP
  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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary outcome measure is weight loss with a goal of 7% of initial weight.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Geoffrey C Williams, MD, PhD, University ofRochester
  • Principal Investigator: Heather Patrick, PhD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24895

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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