T2P2: TODAY2 Phase 2 Follow-up

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT02310724

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), National Eye Institute (NEI) (NIH)

517

Enrollment

Locations

70.6

Actual Duration (Months)

34.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of T2P2 is to track the progression of T2D and related comorbidities and complications in the TODAY cohort as they transition to young adulthood. We hypothesize that:

Youth-onset type 2 diabetes (T2D) will progress rapidly and result in high rates of diabetes-related medical complications and comorbidities.
The rapid rate of progression is related to increased insulin resistance characteristic of puberty, worse β-cell function, degree of glycemic control, control of non-glycemic factors, and obesity itself.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Other: TODAY cohort

Study Design

Study Type:

Observational

Actual Enrollment :

517 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Long-term Post-Intervention Follow-up of the TODAY Cohort (Treatment Options for Type 2 Diabetes in Youth and Adolescents)

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jan 17, 2020

Actual Study Completion Date :

Jan 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
TODAY cohort All subjects randomized to the TODAY clinical trial are eligible to participate in T2P2. The study performs long-term observation only and administers no treatment, care, or management.	Other: TODAY cohort This protocol is observation only and involves no intervention, care, treatment, or management.

Arm

Intervention/Treatment

TODAY cohort

All subjects randomized to the TODAY clinical trial are eligible to participate in T2P2. The study performs long-term observation only and administers no treatment, care, or management.

Other: TODAY cohort

This protocol is observation only and involves no intervention, care, treatment, or management.

Outcome Measures

Primary Outcome Measures

diabetic retinopathy [year 4]
a microvascular complication determined by fundus photography
microalbuminuria [every 12 months]
a microvascular complication determined by urine albumin excretion >= 30 mg/day
overt diabetic nephropathy [every 12 months]
a microvascular complication determined by glomerular filtration rate < 70 mL/min/1.73m2
peripheral diabetic neuropathy [every 12 months]
a microvascular complication defined as the presence of Michigan Neuropathy Screening Instrument (MNSI) exam score >2 and <8 out of 10 appropriate responses to the Semmes-Weinstein monofilament (SW-MF) in either foot.
cardiac function [year 2]
a macrovascular (cardiovascular) risk indicator determined by echocardiogram
arterial stiffness [year 5]
a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity
cardiovascular risk lipid values [every 12 months]
a macrovascular (cardiovascular) risk indicator determined by abnormal lipid value for LDL (>= 130 mg/dL) or triglycerides (>= 300 mg/dL)

Secondary Outcome Measures

glycemic control [every 12 months]
determined by HbA1c (annual)
psychological disorder [every 12 months]
determined by scores on the following participant self-report standard surveys: (a) the Beck Depression Inventory II (BDI-II), (b) the Patient Health Questionnaire (PHQ) scales for somatic symptoms, anxiety, and alcohol use; participants are also interviewed about emotional or mental health problems involving referral, treatment, or hospitalization, and psychiatric diagnoses made by a non-study source that can be confirmed according to standard study criteria from acquired medical records are also recorded
body composition [every 12 months]
determined by body mass index (BMI) computed from physical measurements of height and weight
insulin sensitivity and beta cell function [participant years 6 and 9 from baseline]
determined by oral glucose tolerance test (at 6 and 9 years from randomization) to derive measures of insulin sensitivity (1/insulin0), insulin secretion (ΔC-peptide30-0/Δglucose30-0, Δinsulin30-0/Δglucose30-0 if not on insulin), and the oral disposition index (oDI = insulin sensitivity x insulin secretion)
eating disorder [every 12 months]
determined by score on participant self report questionnaire Eating Disorder Diagnostic Scale (EDDS)
health-related quality of life [every 12 months]
determined by score on the participant self report questionnaire Pediatric Quality of Life Inventory version 4.0 with age-specific versions for teen (13-18), young adult (19-25), and adult (≥26)
blood pressure [every 12 months]
determined by collection of blood pressure
sleep function [years 2-3]
determined by scores on standard questionnaires and in-lab polysomnogram
life stress [every 12 months]
determined by participant self report questionnaire based on the Yeaworth Adolescent Life Change Event Scale
healthcare usage [every 6 months]
determined by participant self report about visits, referrals, treatments, tests, and procedures related to healthcare

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participated in TODAY clinical trial.

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Los Angeles	Los Angeles	California	United States	90027
2	University of Colorado Denver Children's Hospital	Aurora	Colorado	United States	80045
3	Yale University School of Medicine Department of Pediatrics	New Haven	Connecticut	United States	06520
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
5	Joslin Diabetes Center	Boston	Massachusetts	United States	02215
6	Saint Louis University	Saint Louis	Missouri	United States	63104
7	Washington University	Saint Louis	Missouri	United States	63110
8	Columbia University Naomi Berrie Diabetes Center	New York	New York	United States	10032
9	SUNY Upstate New York University	Syracuse	New York	United States	13210
10	Case Western Reserve University Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106
11	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma	United States	73104
12	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
13	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224
14	Baylor College of Medicine	Houston	Texas	United States	77030
15	University of Texas Health Sciences Center	San Antonio	Texas	United States	78229

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)
National Eye Institute (NEI)

Investigators

Study Chair: Philip S Zeitler, MD PhD, University of Colorado Denver Children's Hospital
Principal Investigator: Silva Arslanian, MD, University of Pittsburgh
Principal Investigator: Sonia Caprio, MD, Yale University
Principal Investigator: Jeanie B Tryggestad, MD, University of Oklahoma Health Science Center
Principal Investigator: Mitchell E Geffner, MD, Children's Hospital Los Angeles
Principal Investigator: Robin S Goland, MD, Columbia University Naomi Berrie Diabetes Center
Principal Investigator: Lorraine L Katz, MD, Children's Hospital of Philadelphia
Principal Investigator: Lori MB Laffel, MD, Joslin Diabetes Center
Principal Investigator: Jane L Lynch, MD, University of Texas Health Sciences Center at San Antonio
Principal Investigator: Siripoom V McKay, MD, Baylor College of Medicine
Principal Investigator: Rose Gubitosi-Klug, MD, Case Western Reserve University Rainbow Babies and Children's Hospital
Principal Investigator: David M Nathan, MD, Massachusetts General Hospital
Principal Investigator: Sherida E Tollefsen, MD, St. Louis University
Principal Investigator: Ruth S Weinstock, MD PhD, SUNY Upstate Medical Center
Principal Investigator: Neil H White, MD, Washington University School of Medicine