TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study

NCT01364350 | Completed DMC

• 1 other identifier: DK61230-T2P1
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 16

Brief Summary

The purpose of this study is to continue to follow participants in the TODAY clinical trial as they transition to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months (phase 1), during which time the TODAY data are analyzed and findings interpreted to develop a long-term observational protocol (phase 2). Data are collected during phase 1 for descriptive purposes; there is no primary hypothesis.

Conditions

Diabetes Mellitus Type 2 in Obese

Keywords

type 2 diabetes mellitus; pediatrics; post-intervention study; metformin; complications

Outcome Measures

Primary Outcomes (1)

• effects of TODAY treatment assignment on long-term glycemic control

  The primary objective of the first phase of TODAY2 is to begin to examine the persistence of effects of the TODAY treatment assignment on long-term glycemic control following discontinuation of randomized treatment. During this period, results of TODAY are produced and used to define additional outcomes for the second phase of TODAY2.

  observed for 2 years in phase 1

Secondary Outcomes (5)

• glycemic control

  observed for 2 years in phase 1

• safety

  observed for 2 years in phase 1

• insulin sensitivity and secretion

  observed for 2 years in phase 1

• cardiovascular risk factors

  observed for 2 years in phase 1

• microvascular complications

  observed for 2 years in phase 1

Study Arms (1)

TODAY cohort

The cohort of participants diagnosed with type 2 diabetes ages 10 to \<18 and obese at time of diagnosis who participated in the TODAY clinical trial are recruited, consented and followed.

Other: standard of care in general clinical practice

Interventions

standard of care in general clinical practice OTHER

Participants consenting to receive study-provided care may be treated with metformin, insulin, statin, and ace-inhibitor, as needed for glycemic control and for comorbid conditions.

TODAY cohort

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

participants in the TODAY clinical trial

You may qualify if:

• Participated in the TODAY clinical trial.
• Provided informed consent to participate in T2P1.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (16)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

University of Colorado Denver

Denver, Colorado, 80262, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

George Washington University Biostatistics Center

Rockville, Maryland, 20852, United States

Location

Massachusetts General Hospital Diabetes Center

Boston, Massachusetts, 02114, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13214, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (4)

• TODAY Study Group. Postintervention Effects of Varying Treatment Arms on Glycemic Failure and beta-Cell Function in the TODAY Trial. Diabetes Care. 2021 Jan;44(1):75-80. doi: 10.2337/dc20-0622. Epub 2020 Nov 10.

  PMID: 33290248 BACKGROUND

• TODAY Study Group; Shah RD, Braffett BH, Tryggestad JB, Hughan KS, Dhaliwal R, Nadeau KJ, Levitt Katz LE, Gidding SS. Cardiovascular risk factor progression in adolescents and young adults with youth-onset type 2 diabetes. J Diabetes Complications. 2022 Mar;36(3):108123. doi: 10.1016/j.jdiacomp.2021.108123. Epub 2022 Jan 3.

  PMID: 35123868 DERIVED

• Trief PM, Uschner D, Tung M, Marcus MD, Rayas M, MacLeish S, Farrell R, Keady J, Chao L, Weinstock RS. Diabetes Distress in Young Adults With Youth-Onset Type 2 Diabetes: TODAY2 Study Results. Diabetes Care. 2022 Mar 1;45(3):529-537. doi: 10.2337/dc21-1689.

  PMID: 35015056 DERIVED

• TODAY Study Group; Bjornstad P, Drews KL, Caprio S, Gubitosi-Klug R, Nathan DM, Tesfaldet B, Tryggestad J, White NH, Zeitler P. Long-Term Complications in Youth-Onset Type 2 Diabetes. N Engl J Med. 2021 Jul 29;385(5):416-426. doi: 10.1056/NEJMoa2100165.

  PMID: 34320286 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine are collected on an annual basis and sent to the Central Biospecimen Laboratory for analysis and storage. Analyses performed on an annual basis are: HbA1c, insulin sensitivity and secreation (fasting glucose, insulin, C-peptide, and proinsulin), 2-hour OGTT, pancreatic autoimmunity, serum creatinine, liver function tests, lipids (LDL, triglycerides, free fatty acids, lipoprotein subclass levels, average LDL particle density, and total apoB levels), cardiovascular risk factors (fibrinogen, c-reactive protein, homocysteine vitamin B-12, plasminogran activator inhibitor-1, interleukin-6), microalbumin. HbA1c is also analyzed quarterly.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Silva Arslanian, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Sonia Caprio, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Leona Cuttler, MD

  CWRU Rainbow Babies and Children's Hospital

  PRINCIPAL INVESTIGATOR

• Ken Copeland, MD

  University of Oklahoma Health Science Center

  PRINCIPAL INVESTIGATOR

• Mitch Geffner, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

• Robin Goland, MD

  Columbia University Naomi Berrie Diabetes Center

  PRINCIPAL INVESTIGATOR

• Lorraine Katz, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Lori Laffel, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

• Barbara Linder, MD PhD

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

  STUDY DIRECTOR

• Jane Lynch, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

• Siripoom McKay, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• David Nathan, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Sherida Tollefsen, MD

  Saint Louis University Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Ruth Weinstock, MD PhD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

• Neil White, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Phil Zeitler, MD PhD

  University of Colorado, Denver

  STUDY CHAIR

• Kathryn Hirst, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Coordinating Center

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: June 2, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

US (16)