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Diabetes Prevention Program Outcomes Study (DPPOS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00038727
First Posted: June 5, 2002
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Aging (NIA)
National Institute on Minority Health and Health Disparities (NIMHD)
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Center for Research Resources (NCRR)
Office of Research on Women's Health (ORWH)
Centers for Disease Control and Prevention
American Diabetes Association
Indian Health Service
General Clinical Research Program
VA Office of Research and Development
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Results First Submitted: February 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Diabetes Mellitus
Cancer
CVD
Interventions: Behavioral: DPPOS Group Lifestyle
Drug: Metformin
Behavioral: DPPOS Boost Lifestyle
Behavioral: Intensive Lifestyle Group Session

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All surviving DPP participants with consent were invited to enroll into DPPOS throughout the follow-up period. The majority of DPPOS participants were enrolled in 2002-2003.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
DPPOS covers 3 funding phases for the 3 study phases: DPPOS-1 (2002-2008), DPPOS-2 (2009-2014), DPPOS-3 (2015-2021). The groups are defined using the original randomized groups from DPP with recruitment period of 1996-1998.

Reporting Groups
  Description
1 Original Lifestyle

Boost / Lifestyle, previously Intensive Lifestyle during the DPP

Group Lifestyle: Quarterly group lifestyle sessions

Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.

2 Original Metformin

Metformin / Lifestyle, previously the metformin treatment group during DPP

Group Lifestyle: Quarterly group lifestyle sessions

Metformin: Administered as 850mg twice per day

3 Original Placebo

Group Lifestyle, previously placebo treated participants during DPP

Group Lifestyle: Quarterly group lifestyle sessions


Participant Flow:   Overall Study
    1 Original Lifestyle   2 Original Metformin   3 Original Placebo
STARTED   916 [1]   927 [1]   936 [1] 
DPPOS Phase 1 Primary   910 [2]   924 [2]   932 [2] 
DPPOS Phase 2 Enrolled   915 [3]   926 [3]   935 [3] 
DPPOS Phase 2 Primary   751 [3]   772 [3]   780 [3] 
DPPOS Phase 3 Enrolled [4]   916   927   936 
COMPLETED   916   927   936 
NOT COMPLETED   0   0   0 
[1] Includes all enrollees from DPPOS 1-3
[2] As reported in the Lancet 2009
[3] As reported in Lancet Diabetes and Endocrinology 2015
[4] As of February 2016



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 Original Lifestyle

randomized to unmasked Intensive Lifestyle during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2

DPPOS Group Lifestyle: Quarterly group lifestyle sessions

DPPOS Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.

Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions

2 Original Metformin

randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.

DPPOS Group Lifestyle: Quarterly group lifestyle sessions

Metformin: Administered as 850mg twice per day, masked in DPP and open label in DPPOS

Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions

3 Original Placebo

randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2

DPPOS Group Lifestyle: Quarterly group lifestyle sessions

Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions

Total Total of all reporting groups

Baseline Measures
   1 Original Lifestyle   2 Original Metformin   3 Original Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 916   927   936   2779 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 915   926   935   2776 
   54  (11)   54  (10)   54  (10)   54  (10) 
[1] An additional 3 participants were enrolled after publication
Age 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 916   927   936   2779 
   51.2  (11.1)   51.3  (10.1)   50.7  (10.0)   51.1  (10.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 916   927   936   2779 
Female      624  68.1%      620  66.9%      645  68.9%      1889  68.0% 
Male      292  31.9%      307  33.1%      291  31.1%      890  32.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 916   927   936   2779 
American Indian or Alaska Native      54   5.9%      46   5.0%      55   5.9%      155   5.6% 
Asian      44   4.8%      28   3.0%      40   4.3%      112   4.0% 
Native Hawaiian or Other Pacific Islander      8   0.9%      1   0.1%      1   0.1%      10   0.4% 
Black or African American      173  18.9%      182  19.6%      189  20.2%      544  19.6% 
White      596  65.1%      628  67.7%      612  65.4%      1836  66.1% 
More than one race      19   2.1%      21   2.3%      19   2.0%      59   2.1% 
Unknown or Not Reported      22   2.4%      21   2.3%      20   2.1%      63   2.3% 
Region of Enrollment 
[Units: Participants]
       
United States         
Participants Analyzed 
[Units: Participants]
 916   927   936   2779 
United States   916   927   936   2779 
BMI 
[Units: Kg/m2]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 916   927   936   2779 
   33.7  (6.5)   33.8  (6.5)   34.0  (6.5)   33.8  (6.5) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Development of Diabetes.   [ Time Frame: 2008 ]

2.  Primary:   Prevalence of Aggregate Microvascular Complication   [ Time Frame: 2012-2013 ]

3.  Primary:   Total Cancer Except Non-melanoma Skin Cancer   [ Time Frame: 1996-2021 ]
Results not yet reported.   Anticipated Reporting Date:   06/2021  

4.  Primary:   MACE   [ Time Frame: 1996-2025 ]
Results not yet reported.   Anticipated Reporting Date:   06/2025  

5.  Secondary:   Microvascular and Cardiovascular Disease Risk Factors   [ Time Frame: 2021 ]
Results not yet reported.   Anticipated Reporting Date:   04/2022  

6.  Secondary:   Aging Related Outcomes - Cognitive and Physical Function   [ Time Frame: 2010 and 2012 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Subclinical Atherosclerosis   [ Time Frame: 2012 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Quality of Life and Economic Analyses   [ Time Frame: 2002-2013 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marinella Temprosa, PI of Coordinating Center
Organization: George Washington University
phone: 3018819260
e-mail: ella@bsc.gwu.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00038727     History of Changes
Obsolete Identifiers: NCT00353314
Other Study ID Numbers: IND - DK048489
U01DK048489 ( U.S. NIH Grant/Contract )
First Submitted: June 4, 2002
First Posted: June 5, 2002
Results First Submitted: February 21, 2017
Results First Posted: October 24, 2017
Last Update Posted: October 24, 2017