TODAY Genetics Study (TODAY Genetics)
Study Design: Cohort
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 2
Duration: 2008 – 2015
# Recruitment Centers: 15
Treatment: None, observational only
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL: https://clinicaltrials.gov/ct2/show/NCT00722397
Increases in childhood obesity have been accompanied by an increased prevalence of type 2 diabetes mellitus (T2DM) in children and adolescents. Research has shown the importance of adequate treatment and management on the vascular disease progression of T2DM in adults, but research on the treatment and clinical course of T2DM in youth has been limited. the TODAY (Treatment Options for Type 2 Diabetes in Adolescents & Youth) study, was a randomized clinical trial of treatment for adolescents diagnosed with T2DM.
The TODAY Genetics study is an extension of the TODAY interventional trial. The primary objective of the TODAY Genetics Study is to explore relationships between candidate genes and T2DM using blood and phenotypic information collected from participants. In addition, the study will investigate the role of genetics in obesity, insulin resistance, and cardiac risk in T2DM patients.
Individuals who were diagnosed with T2DM and had BMI ≥ 85th percentile while under the age of 18 are recruited from TODAY clinical centers and collaborators. Once enrolled, participants provide a blood samples for analysis of diabetes type and DNA extraction. Information on participant and family medical history is also collected.
Note: Phenotypic data and biosamples may be requested through the main TODAY study.
The primary objective of the TODAY Genetics Study is to explore relationships between candidate genes and T2DM using blood and phenotypic information collected from participants. In addition, the study will investigate the role of genetics in obesity, insulin resistance, and cardiac risk in T2DM patients.
This study will analyze genetic data to explore the role of genetics in pediatric patients with type 2 diabetes. Phenotype data, including participant and family medical history, and laboratory values, including serum glucose, C-peptide, and pancreatic autoimmunity antibodies, will also be assessed.
Individuals who met the following criteria were eligible for enrollment:
- Diabetes by ADA criteria (laboratory determinations of fasting glucose ≥ 126 mg/dL, random glucose ≥ 200 mg/dL, or two-hour oral glucose tolerance test (OGTT) glucose ≥ 200 mg/dL). Diagnosis must be documented and confirmed in medical record or via a laboratory determination fo HbA1c ≥ 7%. For asymptomatic patients diagnosed with diabetes with a normal fasting glucose but an elevated two-hour glucose during an OGTT, the HbA1c must be ≥ 6%.
- BMI ≥ 85th percentile documented at time of diagnosis or screening.
- Age < 18 at time of diagnosis
Exclusion criteria for the study include:
- Genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
- Patient on medication known to affect glucose tolerance, insulin sensitivity or secretion within 60 days of the time of diagnosis. If diagnosis is confirmed after the patient has been off the medication for 60 days, the patient may be included. Exclusionary medications include (but are not limited to) inhaled steroids at dose above 1000 mcg daily fluticasone equivalent, oral glucocorticoids, antirejection or chemotherapy agents, and atypical antipsychotics.