Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM) (LO5/HY5)

• ClinicalTrials.gov Identifier: NCT00879203
• Recruitment Status: Completed
• First Posted: April 9, 2009
• Last Update Posted: November 2, 2016
• Sponsor: Washington University School of Medicine
• Collaborators: National Institutes of Health (NIH); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Washington University School of Medicine

Tracking Information

• First Submitted Date: April 7, 2009
• First Posted Date: April 9, 2009
• Last Update Posted Date: November 2, 2016
• Study Start Date: November 2008
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM)
• Official Title: Glycemic Control, Brain Structure and Cognition in Youth With T1DM

Brief Summary

LO5 study: The investigators are inviting a new group of youth (ages 7-16) who have been recently diagnosed with type 1 diabetes and their non-diabetic siblings. These youth will complete cognitive tests and a MRI scan of the brain. This scan uses strong magnets to obtain pictures and does not involve any radiation or injections. The investigators will recruit patients within three months of their diagnosis date. The study entails 1 study visit that lasts 3.5 hours. Evening and weekend times are available. The investigators plan to enroll 135 participants.

HY5 study: The investigators are inviting a cohort of youth and young adults (ages 9-21) with type 1 diabetes and their non-diabetic siblings for a follow-up to a study they have already completed. This group of people will complete several memory and thinking tests along with several MRI scans of their brain, just as they did at their previous visits. The investigators plan to enroll 150 participants.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample

Study Population

LO5: Youth with type 1 diabetes (T1DM) between the ages of 7-16 who have been diagnosed within the previous 3 months. Non-diabetic siblings of the participants with T1DM aged 7-16 years old.

HY5: Youth and young adults (ages 9-21) who have already completed an earlier study with the lab.

Condition

• Type 1 Diabetes Mellitis
• Cognition

• Intervention: Not Provided

Study Groups/Cohorts

• Type 1 Diabetes (T1DM)
  Youth and young adults with T1DM
• Non diabetic siblings
  Non diabetic, young siblings of T1DM participants

• Publications *: Perantie DC, Koller JM, Weaver PM, Lugar HM, Black KJ, White NH, Hershey T. Prospectively determined impact of type 1 diabetes on brain volume during development. Diabetes. 2011 Nov;60(11):3006-14. doi: 10.2337/db11-0589. Epub 2011 Sep 27.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 31, 2016): 230
• Original Estimated Enrollment (submitted: April 8, 2009): 285
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

LO5:

Inclusion Criteria for Participants with Type 1 Diabetes:

• Between the ages of 7 and 16
• Diagnosed with type 1 diabetes within 3 months

Inclusion Criteria for Participants without Type 1 Diabetes:

• Between the ages of 7 and 16

Exclusion Criteria for Participants with Type 1 Diabetes:

• Pregnant or lactating
• Chronic disease other than T1DM, well-controlled asthma, or Hashimoto's thyroiditis
• Other current serious medical illness
• Psychiatric illness
• Psychoactive drug dependence
• Neurological illness (except T1DM-related): stroke, seizure, major loss of consciousness, head injuries, encephalitis, or hydrocephalus, blindness, deafness
• Use of psychoactive medications or exposure to neuroleptics (except that exposures of less than 1 month, occurring more than 5 years ago, will be allowed)
• Use of dopamine depleting agents or stimulants such as Ritalin, Cylert, Adderall
• Pre-maturity at birth of more than 4 wks early with complications (e.g. on respirator at NICU)
• Inability to complete MRI scan (e.g. claustrophobia, metal implants)
• Full set (top and bottom) of orthodontic braces (Half set braces, fillings, and retainers are OK)

Exclusion Criteria for Participants without Type 1 Diabetes:

• Same as above (except cannot have type 1 diabetes)

HY5: Must have been a participant in our earlier study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 16 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00879203
• Other Study ID Numbers: 07-1258; R01DK064832-06 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Washington University School of Medicine
• Original Responsible Party: Tamara G. Hershey, PhD, Washington University School of Medicine
• Current Study Sponsor: Washington University School of Medicine
• Original Study Sponsor: Same as current

Collaborators

• National Institutes of Health (NIH)
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Tamara G. Hershey, PhD; Washington University School of Medicine

• PRS Account: Washington University School of Medicine
• Verification Date: October 2016