Sponsor study identifier
interventional
68
0 countries
N/A
Study Start
January 2011
Actual (reported)Primary Completion
November 2014
Actual (reported)Study Completion
November 2014
Actual (reported)The goal of this study is to examine the effect of chronic and acute hyperglycemia in type 1 diabetes mellitus (T1DM) on brain glutamate levels using magnetic resonance spectroscopy (MRS), and associations of brain glutamate with symptoms of depression.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2011
Actual (reported)November 2014
Actual (reported)November 2014
Actual (reported)April 20, 2022
Actual (reported)May 2, 2022
Actual (reported)Anterior cingulate cortex glutamate concentration during Baseline Euglycemia
mmol/kg wet weight of brain tissue
Baseline Euglycemia
Change in anterior cingulate cortex glutamate concentration from Baseline Euglycemia to Hyperglycemia
mmol/kg wet weight of brain tissue
During the MRI scanning visit with hyperglycemic clamp, up to 180 minutes
Change in anterior cingulate cortex glutamate concentration from Baseline Euglycemia to Hyperinsulinemic Euglycemia
During the MRI scanning visit with hyperinsulinemic euglycemic clamp, up to 180 minutes
Subjects with T1DM (Groups 1 and 2): 1) receive a low dose insulin infusion to reduce their plasma glucose to euglycemia; 2) receive a continuous infusion of insulin at the rate of 0.25 milli-Units/kg/min to maintain euglycemia during a Baseline MRI scanning period. Subjects without diabetes (Groups 3 and 4) are scanned during a Baseline MRI scanning period (no intervention is needed to maintain euglycemia in these subjects).
Subjects with T1DM (Groups 1 and 2): 1) receive a primed variable glucose infusion to attain a target increase in glycemic level of +5.5 mmol/L; 2) receive a continuous infusion of insulin at the rate of 0.25 milli-Units/kg/min. Subjects without diabetes (Groups 3 and 4): 1) receive a primed variable glucose infusion to attain a target increase in glycemic level of +5.5 mmol/L.
Subjects receive variable rates of glucose or insulin infusions to adjust and maintain desired plasma glucose or insulin levels.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Bolo NR, Jacobson AM, Musen G, Keshavan MS, Simonson DC. Acute Hyperglycemia Increases Brain Pregenual Anterior Cingulate Cortex Glutamate Concentrations in Type 1 Diabetes. Diabetes. 2020 Jul;69(7):1528-1539. doi: 10.2337/db19-0936. Epub 2020 Apr 15.
Bolo NR, Jacobson AM, Musen G, Simonson DC. Hyperglycemia and hyperinsulinemia effects on anterior cingulate cortex myoinositol-relation to brain network functional connectivity in healthy adults. J Neurophysiol. 2022 May 1;127(5):1426-1437. doi: 10.1152/jn.00408.2021. Epub 2022 Apr 13.
Nicolas R Bolo, PhD
Beth Israel Deaconess Medical Center
68 participants (actual enrollment reported by the registry).
First Submitted
April 20, 2022
Improving Mood in Assisted Living Settings
Change in occipital lobe glutamate concentration from Baseline Euglycemia to Hyperglycemia
During the MRI scanning visit with hyperglycemic clamp, up to 180 minutes
Change in occipital lobe glutamate concentration from Baseline Euglycemia to Hyperinsulinemic Euglycemia
During the MRI scanning visit with hyperinsulinemic euglycemic clamp, up to 180 minutes
Change in anterior cingulate cortex myo-inositol concentration from Baseline Euglycemia to Hyperglycemia
During the MRI scanning visit with hyperglycemic clamp, up to 180 minutes
Change in anterior cingulate cortex myo-inositol concentration from Baseline Euglycemia to Hyperinsulinemic Euglycemia
During the MRI scanning visit with hyperinsulinemic euglycemic clamp, up to 180 minutes
Hamilton Depression rating (HAM-D)
Baseline
Revised Symptom Checklist rating (SCL-90-R)
Baseline
Wechsler Abbreviated Scale of Intelligence - intelligence quotient (WASI-IQ)
Baseline
Subjects without diabetes or depression (Group 3) have a second study visit at least 15 days after the Hyperglycemic Clamp visit. They receive a variable insulin infusion to match individual insulin levels to the levels attained during the Hyperglycemic Clamp and they receive a variable glucose infusion to maintain euglycemia.
Contact the study team to confirm eligibility.
First Posted
May 2, 2022
Study Start
January 2011
Actual (reported)Primary Completion
November 2014
Actual (reported)Study Completion
November 2014
Actual (reported)Last Updated
May 5, 2022
Record last verified: 2022-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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