Type 2 DiabetesNCT00722397
TODAY Genetics Study
An observational study of Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 25 sites in United States.
Trial summary
The TODAY study group has prepared a protocol with the primary objective of collecting blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes (T2D), as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 2,654 participants
- Where
- 25 sitesUnited States
- Study dates
- Aug 2008to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Recruitment is conducted within a 'catchment' area that includes (a) the patient pools of the 15 TODAY clinical centers and (b) collaborating clinics and physicians who either refer subjects to a TODAY site or obtain IRB approval to conduct the protocol at their own locale.
Who may be able to join
- 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) documented and confirmed in medical record or a laboratory determination of 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 at screening.
- Age < 18 at time of diagnosis.
- Signed informed consent and assent forms as appropriate.
Who cannot join
- 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 (e.g., tacrolimus, L-asparaginase),
- atypical antipsychotics.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Emory University
Atlanta, Georgia, 30322
University of Colorado Denver
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Joslin Diabetes Center
Boston, Massachusetts, 02215
Case Western Reserve University
Cleveland, Ohio, 44106
University of Florida
Gainesville, Florida, 32611
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Baylor College of Medicine
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Kansas City Children's Mercy Hospital
Kansas City, Missouri, 64108
UAMS Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Texas Tech University Health Science Center
Lubbock, Texas, 79430
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06519
Columbia University
New York, New York, 10032
University of Oklahoma
Oklahoma City, Oklahoma, 73117
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
George Washington University Biostatistics Center
Rockville, Maryland, 20852
University of Texas Health Science Center
San Antonio, Texas, 78207
UCSD Rady Children's Hospital
San Diego, California, 92123
St Louis University
St Louis, Missouri, 63104
Washington University
St Louis, Missouri, 63110
State University of New York Upstate Medical University
Syracuse, New York, 13214
About this study
Official title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Genetics Study
The TODAY study group has prepared a protocol with the primary objective of collecting blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes (T2D), as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. Participation in the genetics study includes a blood draw for analysis of diabetes type and DNA extraction, as well as collection of basic family and medical history. Appropriate informed consent and assent are obtained from all participants to extract DNA and send blood, genetic material, and medical history to the Central Repository of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The data are kept indefinitely by the Central Repository. The NIDDK will issue requests for proposals (RFP) throughout the scientific community for research that may help in the development of new diagnostic tests, new treatments, and new ways to prevent diabetes and other related comorbidities.
- Conditions
- Type 2 Diabetes
- Keywords
- genetics, pediatrics
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood draw to be processed and analyzed to yield genetic data.
Blood is sent to the DNA processing center identified by NIDDK for processing and shipment to the NIDDK Repository.
Measured: Blood is drawn at the single study visit.
Secondary outcomes (2)
Phenotype data.
Demographic, medical history, and other data about participant and family, by self-report.
Measured: Collected at single study visit.
Laboratory values.
Serum glucose, C-peptide, and pancreatic autoimmunity antibodies determined by study central laboratory.
Measured: Single study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,654 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Phil Zeitler, MD PhD, Principal investigator, University of Colorado, DenverKathryn Hirst, PhD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722397
- Sponsor's protocol ID
- IND - DK61230-GENETICS
- Other IDs
- DK61230
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2008
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Srinivasan S, Chen L, Todd J, Divers J, Gidding S, Chernausek S, Gubitosi-Klug RA, Kelsey MM, Shah R, Black MH, Wagenknecht LE, Manning A, Flannick J, Imperatore G, Mercader JM, Dabelea D, Florez JC; ProDiGY Consortium. The First Genome-Wide Association Study for Type 2 Diabetes in Youth: The Progress in Diabetes Genetics in Youth (ProDiGY) Consortium. Diabetes. 2021 Apr;70(4):996-1005. doi: 10.2337/db20-0443. Epub 2021 Jan 21.
PubMed 33479058
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Genetics Study
- ClinicalTrials.gov ID
- NCT00722397
- Acronym / sponsor ID
- IND - DK61230-GENETICS
- Conditions
- Type 2 Diabetes
- Keywords
- genetics, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,654 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Aug 2008
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TODAY study group has prepared a protocol with the primary objective of collecting blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes (T2D), as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. Participation in the genetics study includes a blood draw for analysis of diabetes type and DNA extraction, as well as collection of basic family and medical history. Appropriate informed consent and assent are obtained from all participants to extract DNA and send blood, genetic material, and medical history to the Central Repository of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The data are kept indefinitely by the Central Repository. The NIDDK will issue requests for proposals (RFP) throughout the scientific community for research that may help in the development of new diagnostic tests, new treatments, and new ways to prevent diabetes and other related comorbidities.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Recruitment is conducted within a 'catchment' area that includes (a) the patient pools of the 15 TODAY clinical centers and (b) collaborating clinics and physicians who either refer subjects to a TODAY site or obtain IRB approval to conduct the protocol at their own locale.
Key inclusion criteria (4 listed)
- 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) documented and confirmed in medical record or a laboratory determination of 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 at screening.
- Age < 18 at time of diagnosis.
- Signed informed consent and assent forms as appropriate.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood draw to be processed and analyzed to yield genetic data.
Time frame: Blood is drawn at the single study visit.
Blood is sent to the DNA processing center identified by NIDDK for processing and shipment to the NIDDK Repository.
2 secondary outcomes
Phenotype data.
Time frame: Collected at single study visit.
Laboratory values.
Time frame: Single study visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Results publication: PubMed 33479058Srinivasan S, Chen L, Todd J, Divers J, Gidding S, Chernausek S, Gubitosi-Klug RA, Kelsey MM, Shah R, Black MH, Wagenknecht LE, Manning A, Flannick J, Imperatore G, Mercader JM, Dabelea D, Florez JC; ProDiGY Consortium. The First Genome-Wide Association Study for Type 2 Diabetes in Youth: The Progress in Diabetes Genetics in Youth (ProDiGY) Consortium. Diabetes. 2021 Apr;70(4):996-1005. doi: 10.2337/db20-0443. Epub 2021 Jan 21.
Related trials for Type 2 Diabetes
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Active, not recruiting
Chrono Nutrition and Insulin Resistance in Diabetes
Diabetes Mellitus, Type 2
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, Type 2 Diabetes, and Increased Cardiovascular Risk
Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phil Zeitler, MD PhD principal investigator
University of Colorado, Denver
Kathryn Hirst, PhD principal investigator
George Washington University
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood draw to be processed and analyzed to yield genetic data. (time frame: Blood is drawn at the single study visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00722397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.