TODAY2 Phase 2 Follow-up

Type 2 Diabetes Clinical Trial

— T2P2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310724
• Other study ID #: DK61230-T2P2
• Secondary ID: U01DK061230
• Status: Completed
• Start date: March 1, 2014
• Est. completion date: January 17, 2020

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: January 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Participated in TODAY clinical trial.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• TODAY cohort
This protocol is observation only and involves no intervention, care, treatment, or management.

Locations

Country	Name	City	State
United States	University of Colorado Denver Children's Hospital	Aurora	Colorado
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Case Western Reserve University Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Yale University School of Medicine Department of Pediatrics	New Haven	Connecticut
United States	Columbia University Naomi Berrie Diabetes Center	New York	New York
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Saint Louis University	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	University of Texas Health Sciences Center	San Antonio	Texas
United States	SUNY Upstate New York University	Syracuse	New York

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

TODAY Study Group. Health Care Coverage and Glycemic Control in Young Adults With Youth-Onset Type 2 Diabetes: Results From the TODAY2 Study. Diabetes Care. 2020 Oct;43(10):2469-2477. doi: 10.2337/dc20-0760. Epub 2020 Aug 10. — View Citation

TODAY Study Group. Longitudinal Changes in Cardiac Structure and Function From Adolescence to Young Adulthood in Participants With Type 2 Diabetes Mellitus: The TODAY Follow-Up Study. Circ Heart Fail. 2020 Jun;13(6):e006685. doi: 10.1161/CIRCHEARTFAILURE. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diabetic retinopathy	a microvascular complication determined by fundus photography	year 4
Primary	microalbuminuria	a microvascular complication determined by urine albumin excretion >= 30 mg/day	every 12 months
Primary	overt diabetic nephropathy	a microvascular complication determined by glomerular filtration rate < 70 mL/min/1.73m2	every 12 months
Primary	peripheral diabetic neuropathy	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.	every 12 months
Primary	cardiac function	a macrovascular (cardiovascular) risk indicator determined by echocardiogram	year 2
Primary	arterial stiffness	a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity	year 5
Primary	cardiovascular risk lipid values	a macrovascular (cardiovascular) risk indicator determined by abnormal lipid value for LDL (>= 130 mg/dL) or triglycerides (>= 300 mg/dL)	every 12 months
Secondary	glycemic control	determined by HbA1c (annual)	every 12 months
Secondary	psychological disorder	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	every 12 months
Secondary	body composition	determined by body mass index (BMI) computed from physical measurements of height and weight	every 12 months
Secondary	insulin sensitivity and beta cell function	determined by oral glucose tolerance test (at 6 and 9 years from randomization) to derive measures of insulin sensitivity (1/insulin0), insulin secretion (?C-peptide30-0/?glucose30-0, ?insulin30-0/?glucose30-0 if not on insulin), and the oral disposition index (oDI = insulin sensitivity x insulin secretion)	participant years 6 and 9 from baseline
Secondary	eating disorder	determined by score on participant self report questionnaire Eating Disorder Diagnostic Scale (EDDS)	every 12 months
Secondary	health-related quality of life	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)	every 12 months
Secondary	blood pressure	determined by collection of blood pressure	every 12 months
Secondary	sleep function	determined by scores on standard questionnaires and in-lab polysomnogram	years 2-3
Secondary	life stress	determined by participant self report questionnaire based on the Yeaworth Adolescent Life Change Event Scale	every 12 months
Secondary	healthcare usage	determined by participant self report about visits, referrals, treatments, tests, and procedures related to healthcare	every 6 months