|
Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) Clinical research trials and Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY). Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial. Human subjects often receive the most effective healthcare possible for their Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY)  Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY)
Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY)
For Condition: Diabetes Mellitus, Type II
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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 mellitus (T2DM) 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 T2DM.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 10 Years/17 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria (during Screening and Run-in period): - Diabetes by ADA criteria (laboratory determinations of fasting glucose 126 mg/dL, random glucose 200 mg/dL, or two-hour OGTT glucose 200 mg/dL) documented and confirmed in medical record. For patients diagnosed with diabetes during screening who have a normal fasting glucose but an elevated two-hour glucose during an OGTT, the HbA1c must be 6%. - Duration since diagnosis less than two years by date of randomization. - BMI 85th percentile documented at time of diagnosis or at screening. - Fasting C-peptide at screening (drawn at least one week after treatment for ketosis or acidosis, if applicable) > 0.6 ng/mL. - Absence of pancreatic autoimmunity (both GAD and ICA512 negative). - Age 10-17, with randomization prior to 18th birthday. - Signed informed consent/assent forms for the pre-randomization period. - A family member or adult closely involved in the daily activities of the child agrees to participate in the child’s treatment. - Fluency in English or Spanish for both child and family member. - Patient and family able to fully participate in trial protocol in the opinion of the investigator. Exclusion Criteria (during Screening and Run-in period): - Participating in another interventional research study protocol in the past 30 days. - Genetic syndrome or disorder known to affect glucose tolerance other than diabetes. - Patient on inhaled steroids at dose above 1000 mcg daily Flovent equivalent. - Patient on a course of oral steroids within the last 60 days or on oral steroids more than 20 days during the past year. - Patient on medication(s) that are known to affect insulin sensitivity or secretion within the last 30 days. - Patient on medication(s) that are known to cause weight gain within the last 30 days. - Patient on any weight-loss medication(s) within the last 30 days. - Patient on medication(s) known to affect the metabolism of study drug. - Inability to comprehend the lowest grade level at which lifestyle intervention materials are prepared, for both child and participating family member. - Females who are pregnant, planning to become pregnant within two years of enrollment, or who admit sexual activity without appropriate contraception. - Calculated creatinine clearance < 70 mL/min. - Any transaminase > 2.5 ULN. If any transaminase 1.5-2.5 times ULN, then patient must be appropriately evaluated by PCP (minimum evaluation includes ceruloplasmin level, alpha-1 antitrypsin phenotype, ANA, anti-smooth muscle antibody, anti-LKM antibody, anti-HCV, and anti-HBc total antibody not IgM, iron, and TIBC) and is eligible if all other causes for elevation are ruled out and it is presumed due only to non-alcoholic fatty liver disease (NAFLD). - Diabetic ketoacidosis (DKA) at any time after diagnosis unless only a single episode of DKA related to a significant medical illness. - Physical limitations preventing patient from being randomized to the lifestyle intervention. - Patient plans to leave the geographic area within one calendar year. - Abnormal reticulocyte count or HbA1c chromatogram at time of screening. - Admitted use of anabolic steroids within the past 60 days. - Other significant organ system illness or condition (including psychiatric or developmental disorder) that would prevent participation in the opinion of the investigator. - Patient participates in a formal weight-loss program. Inclusion Criteria (post Run-in and Randomization): - Duration since diagnosis less than 2 years at randomization. - HbA1c < 8% on metformin alone. - Age 10-17, with randomization before patient is 18 years old. - Signed consent/assent forms for randomization and the post-randomization phase. - A family member or adult closely involved in the daily activities of the child agrees to participate in the child’s treatment. - Fluency in English or Spanish for both child and family member. - Patient and family able to fully participate in trial protocol in the opinion of the investigator. Exclusion Criteria (post Run-in and Randomization): - Refractory hypertension: average systolic blood pressure 150 mmHg or average diastolic blood pressure 95 mmHg despite appropriate medical therapy. - Refractory hyperlipidemia: total cholesterol > 300 mg/dL or LDL > 190 mg/dL or triglycerides > 800 mg/dL, despite appropriate medical therapy. - Refractory anemia: hematocrit < 30% or hemoglobin < 10 gm/dL despite appropriate medical therapy. - Patient on a thiazolidinedione (TZD) within the last 12 weeks. - Patient on non-study diabetes medications within the past 6 weeks. - Patient on inhaled steroids at dose above 1000 mcg daily Flovent equivalent. - Patient on a course of oral steroids within the last 60 days or on oral steroids more than 20 days during the past year. - Patient on medication(s) that are known to affect insulin sensitivity or secretion within the last 30 days. - Patient on medication(s) that are known to cause weight gain within the last 30 days. - Patient on any weight-loss medication(s) within the last 30 days. - Patient on medication(s) known to affect the metabolism of study drug. - Inability to comprehend the lowest grade level at which lifestyle intervention materials are prepared, for both child and participating family member, assessed by mastery of standard diabetes education program administered during run-in. - Inability to comply with requirements of study during run-in period. - Females who are pregnant, planning to become pregnant within two years of enrollment, or who admit sexual activity without appropriate contraception. - Calculated creatinine clearance < 70 mL/min. - Physical limitations preventing patient from being randomized to the lifestyle intervention. - Patient plans to leave the geographic area within one calendar year. - Admitted use of anabolic steroids within 60 days. - Other significant organ system illness or condition (including psychiatric or developmental disorder) that would prevent participation in the opinion of the investigator. - Patient participates in a formal weight loss program. - Episode of DKA during the run-in.
Total Enrollment: 750
Location and Contact Information:
Overall Study Official:
FrancineKaufman, Study Chair, Children's Hospital Los Angeles
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Cynthia Trevino 210-358-7113
State University of New York Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Suzan Carusone 315-464-9006
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Sue McGirk 832-822-3063
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027
United States
Recruiting Veronica Barraza 323-671-7645
University of Oklahoma *Recruiting*
Oklahoma City, Oklahoma, 93104
United States
Recruiting Carol Comp 405-271-8001
Case Western Reserve *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Paul McGuigan 216-844-3661
University of Colorado Health Sciences Center, The Children's Hospital *Recruiting*
Denver, Colorado, 80262
United States
Recruiting Nicole Celona-Jacobs 303-869-3212
Yale University *Recruiting*
New Haven, Connecticut, 06520
United States
Recruiting Cindy Guandalini 203-785-7817
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Kristin Kolenc 412-692-5928
Washington University Department of Pediatrics *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Tracy Jones 314-286-2762
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Cathy Carchidi 267-426-5492
Massachusetts General Hospital Diabetes Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Mary Larkin 617-726-6909
Additional Information:
Study ID Numbers: DK61230;
Study Start Date: May 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081328
Other Diabetes Mellitus, Type Ii Studies:
1. Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY)
Related Studies:
Other Diabetes Mellitus, Type II Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY)
|
|
|
|
|
|
|
|
