Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081328
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2004-04-08
Brief Title:
Treatment Options for Type 2 Diabetes in Adolescents and Youth TODAY
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Studies to Treat Or Prevent Pediatric Type 2 Diabetes STOPP-T2D Treatment Options for Type 2 Diabetes in Adolescents and Youth TODAY Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TODAY
Brief Summary:
The National Institute of Diabetes and Digestive and Kidney Diseases NIDDK of the National Institutes of Health NIH has sponsored a consortium of investigators to conduct a clinical treatment trial Treatment Options for type 2 Diabetes in Adolescents and Youth TODAY
The primary objective of the TODAY trial is to compare the efficacy of three treatment arms on time to treatment failure based on glycemic control The secondary aims are to
compare and evaluate the safety of the three treatment arms
compare the effects of the three treatments on the pathophysiology of type 2 diabetes T2D with regards to beta cell function and insulin resistance body composition nutrition physical activity and aerobic fitness cardiovascular risk factors microvascular complications quality of life and psychological outcomes
evaluate the influence of individual and family behaviors on treatment response and
compare the relative cost effectiveness of the three treatment arms
The three treatment regimens are 1 metformin alone 2 metformin plus rosiglitazone and 3 metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program TLP The study recruits patients over a three-year period and follows patients for a minimum of two years Patients are randomized within two years of the diagnosis of T2D
The primary objective of the TODAY trial is to compare the efficacy of three treatment arms on time to treatment failure based on glycemic control The secondary aims are to
compare and evaluate the safety of the three treatment arms
compare the effects of the three treatments on the pathophysiology of type 2 diabetes T2D with regards to beta cell function and insulin resistance body composition nutrition physical activity and aerobic fitness cardiovascular risk factors microvascular complications quality of life and psychological outcomes
evaluate the influence of individual and family behaviors on treatment response and
compare the relative cost effectiveness of the three treatment arms
The three treatment regimens are 1 metformin alone 2 metformin plus rosiglitazone and 3 metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program TLP The study recruits patients over a three-year period and follows patients for a minimum of two years Patients are randomized within two years of the diagnosis of T2D
Detailed Description:
T2DM has dramatically increased throughout the world in many ethnic groups and among people with diverse social and economic backgrounds Over the last decade the increase in the number of children and youth with T2DM has been labeled an epidemic Before the 1990s it was rare for most pediatric centers to have patients with T2DM By 1994 T2DM patients represented up to 16 of new cases of diabetes in children in urban areas and by 1999 depending on geographic location the range of percent of new cases due to T2DM was between 8-45 and disproportionately represented in minority populations
T2DM in children and youth as in adults is due to the combination of insulin resistance and relative β-cell failure It appears that there are a host of genetic and environmental risk factors for insulin resistance and limited β-cell reserve The epidemic of pediatric T2DM is coincident with the rise in the number of children who are overweight or at risk for overweight and with a decrease in the physical activity pattern of youth There has been a strong association between T2DM and the onset of puberty a positive family history of T2DM and elements of the metabolic syndrome such as acanthosis nigricans and polycystic ovarian syndrome PCOS
Preceding the development of frank diabetes children and youth experience a period of prediabetes Prediabetes is defined as either elevated fasting glucose or impaired glucose tolerance Despite the dramatic increase in the number of cases of prediabetes and T2DM in pediatric populations there have been no published large-scale studies investigating the pathophysiology treatment and complications of these disorders in children and youth The long-term complications and costs associated with T2DM make such studies imperative Between 1997 and 2002 the estimated cost of diabetes with regard to direct medical cost increased from 44 billion to 92 billion and the total cost increased from 98 billion to 132 billion The vast majority of monies are spent on the long-term complications of this disorder Since the long-term microvascular and cardiovascular complications relate to duration of diabetes and to control of glycemia it could be hypothesized that the increasing number of children and youth diagnosed with T2DM if not effectively treated could dramatically add to the economic burden of this disease over the ensuing decades
Except in American Indian youth there are no population-based data available with regard to prevalence of T2DM Instead only clinic-based reports indicate that there has been a tremendous increase in the number of children and adolescents with T2DM T2DM occurs almost exclusively in children and youth who are overweight or at risk for overweight BMI 85th percentile for age At the time of diagnosis most pediatric patients are in the midst of Tanner Stage 2-4 puberty Puberty contributes to insulin resistance due to augmentation of growth hormone secretion and if these normal pubertal physiologic changes are not compensated for by increased insulin secretion frank diabetes will develop Half to three-quarters of patients have a parent and close to ninety percent have at least one first or second degree relative with T2DM The clinical presentation of T2DM in youth ranges from mild asymptomatic hyperglycemia to severe ketoacidosis In those who present with clinical symptoms due to hyperglycemia glycosuria and weight loss are present in 20-40 ketonuria is present in 33 and ketoacidosis is found in 5-10 Patients without clinical symptoms are diagnosed as the result of routine blood or urine testing during a health care visit or by investigating a variety of complaints such as chronic infection sleep apnea hyperlipidemia hypertension and hirsutism or irregular periods associated with PCOS It may be difficult to distinguish T1DM from T2DM at presentation The absence of autoantibodies is a prerequisite for the diagnosis of T2DM In addition evidence of residual insulin secretion is suggestive of T2DM rather than T1DM
Patients with T2DM have dual abnormalities of insulin resistance and insulin deficiency It is hypothesized that to achieve the level of glycemic control required to optimize long-term outcome and decrease or prevent microvascular complications treatment regimens should theoretically be designed to improve insulin resistance and preserve residual β-cell function The available anti-diabetic agents have not been adequately evaluated in pediatric patients This is particularly relevant with regard to using combination therapy to improve glycemic control or lifestyle interventions aimed at obesity and sedentary behavior
T2DM in children and youth as in adults is due to the combination of insulin resistance and relative β-cell failure It appears that there are a host of genetic and environmental risk factors for insulin resistance and limited β-cell reserve The epidemic of pediatric T2DM is coincident with the rise in the number of children who are overweight or at risk for overweight and with a decrease in the physical activity pattern of youth There has been a strong association between T2DM and the onset of puberty a positive family history of T2DM and elements of the metabolic syndrome such as acanthosis nigricans and polycystic ovarian syndrome PCOS
Preceding the development of frank diabetes children and youth experience a period of prediabetes Prediabetes is defined as either elevated fasting glucose or impaired glucose tolerance Despite the dramatic increase in the number of cases of prediabetes and T2DM in pediatric populations there have been no published large-scale studies investigating the pathophysiology treatment and complications of these disorders in children and youth The long-term complications and costs associated with T2DM make such studies imperative Between 1997 and 2002 the estimated cost of diabetes with regard to direct medical cost increased from 44 billion to 92 billion and the total cost increased from 98 billion to 132 billion The vast majority of monies are spent on the long-term complications of this disorder Since the long-term microvascular and cardiovascular complications relate to duration of diabetes and to control of glycemia it could be hypothesized that the increasing number of children and youth diagnosed with T2DM if not effectively treated could dramatically add to the economic burden of this disease over the ensuing decades
Except in American Indian youth there are no population-based data available with regard to prevalence of T2DM Instead only clinic-based reports indicate that there has been a tremendous increase in the number of children and adolescents with T2DM T2DM occurs almost exclusively in children and youth who are overweight or at risk for overweight BMI 85th percentile for age At the time of diagnosis most pediatric patients are in the midst of Tanner Stage 2-4 puberty Puberty contributes to insulin resistance due to augmentation of growth hormone secretion and if these normal pubertal physiologic changes are not compensated for by increased insulin secretion frank diabetes will develop Half to three-quarters of patients have a parent and close to ninety percent have at least one first or second degree relative with T2DM The clinical presentation of T2DM in youth ranges from mild asymptomatic hyperglycemia to severe ketoacidosis In those who present with clinical symptoms due to hyperglycemia glycosuria and weight loss are present in 20-40 ketonuria is present in 33 and ketoacidosis is found in 5-10 Patients without clinical symptoms are diagnosed as the result of routine blood or urine testing during a health care visit or by investigating a variety of complaints such as chronic infection sleep apnea hyperlipidemia hypertension and hirsutism or irregular periods associated with PCOS It may be difficult to distinguish T1DM from T2DM at presentation The absence of autoantibodies is a prerequisite for the diagnosis of T2DM In addition evidence of residual insulin secretion is suggestive of T2DM rather than T1DM
Patients with T2DM have dual abnormalities of insulin resistance and insulin deficiency It is hypothesized that to achieve the level of glycemic control required to optimize long-term outcome and decrease or prevent microvascular complications treatment regimens should theoretically be designed to improve insulin resistance and preserve residual β-cell function The available anti-diabetic agents have not been adequately evaluated in pediatric patients This is particularly relevant with regard to using combination therapy to improve glycemic control or lifestyle interventions aimed at obesity and sedentary behavior
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DK061230 | NIH | None | httpsreporternihgovquickSearchU01DK061230 |