Diabetes Prevention Program Outcomes Study

Cancer Clinical Trial

— DPPOS  

Official title:

Diabetes Prevention Program Outcomes Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00038727
• Other study ID #: DPPOS
• Secondary ID: U01DK048489
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 2002
• Est. completion date: January 2025

Study information

• Verified date: December 2021
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%.

DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations.

The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.

Description:

The current DPPOS Executive Summary and protocol, as well as DPPOS protocol and lifestyle manuals and publications are available at: http://www.dppos.org

Other known NCT identifiers

• NCT00353314

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2779
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older
• Eligibility: Participation as a volunteer in the Diabetes Prevention Program (DPP).

Related Conditions & MeSH terms

• Cancer
• CVD
• Diabetes Mellitus

Intervention

Behavioral:
• DPPOS Group Lifestyle
Quarterly group lifestyle sessions

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

Behavioral:
• 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

Locations

Country	Name	City	State
United States	George Washington University	Rockville	Maryland

Sponsors (14)

Lead Sponsor

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

American Diabetes Association, Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), General Clinical Research Program, Indian Health Service, National Cancer Institute (NCI), National Center for Research Resources (NCRR), National Eye Institute (NEI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute on Minority Health and Health Disparities (NIMHD), Office of Research on Women's Health (ORWH), US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

References & Publications (3)

Diabetes Prevention Program Research Group, Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention P — View Citation

Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol — View Citation

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Diabetes.	Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level >= 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose >= 200 mg/dL [11.1 mmol/L], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test).	Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
Primary	Prevalence of Aggregate Microvascular Complication	Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed).	Outcomes were assessed from 2012-2013 (approximately 2 years).
Primary	Total Cancer Except Non-melanoma Skin Cancer	All primary incident cancers except non-melanoma skin cancer	Outcomes were assessed from 1996-2020 (approximately 24 years).
Primary	Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)	Defined as MI, stroke and CVD death. These outcomes were collected since randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.	Outcomes were assessed from 1996-2025 (approximately 29 years).
Secondary	Subclinical Atherosclerosis	Measured using coronary artery calcification (CAC).	Outcomes were assessed from 2012-2013 (approximately 2 years).
Secondary	Cognitive Function	Cognitive function defined as a composite measure constructed from tests of memory (English Spanish Verbal Learning Test) and executive function (word fluency and Digit Symbol Substitution Test ).	Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
Secondary	Short Physical Performance Battery	Physical function is measured using the short physical performance battery (SPPB), which is comprised of measures of 1) time to walk 3-4 meters, 2) balance, i.e., side-by-side stand, semi-tandem stand, and tandem stand, and 3) repeated chair stands.	Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
Secondary	Frailty	Description: The Cardiovascular Health Study Frailty score is based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.	Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.
Secondary	Mortality	All cause-mortality through clinic reports and National Death Index search	Outcomes were assessed throughout follow-up from 1996 to 2022. National Death Index search conducted in 2019 using early release data as of Dec 2018.

External Links

•   Clinical trials.gov entry for DPP
•   Study website