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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
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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.
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