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Reversibility of Brain Glucose Transport and Metabolism in T2DM: an Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283617
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
This study is designed to test if there is a difference in brain glucose transport kinetics in poorly controlled T2DM individuals with short duration and long duration of diabetes, using non-invasive magnetic resonance spectroscopy (MRSI). Also, if these changes are reversible with improved glucose control will be tested. A better understanding of the impact of duration of diabetes on brain glucose transport function may have important implications for understanding the pathophysiology of brain complications in T2DM.

Condition or disease Intervention/treatment Phase
Diabete Type 2 Behavioral: Intensification of insulin regimen/Nutrition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Reversibility of Brain Glucose Transport and Metabolism in T2DM: an Intervention Study
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Diabetic with short duration
Type 2 diabetics with HbA1c > 7.5 % with short duration of diabetes < 5 years
Behavioral: Intensification of insulin regimen/Nutrition
The intensification of the diabetes regimens will be managed by Dr. Sanchez Rangel, a fully trained attending endocrinologist, The weight goal will be to have no more than 5% weight change. Participants will have regular phone and in-person MD and nutritionist communication over the course of the 12-week study. All individuals will be asked to perform SMBG at least 4 times a day (before breakfast, lunch, dinner, and bedtime). The daily SMBG records will be sent to Dr. Sanchez Rangel weekly for review to guide adjustment of insulin regimens. Target blood glucose levels will be between 80-130 mg/dl before meals and between < 180 mg/dl at bedtime. Throughout the study, individuals will be contacted via telephone call, email or through additional clinic visits as deemed necessary for maintenance of glycemic control. All individuals will receive education regarding the detection and proper management of hypoglycemia.

Experimental: Diabetic with long duration
Type 2 diabetics with HbA1c > 7.5 % with short duration of diabetes > 5 years
Behavioral: Intensification of insulin regimen/Nutrition
The intensification of the diabetes regimens will be managed by Dr. Sanchez Rangel, a fully trained attending endocrinologist, The weight goal will be to have no more than 5% weight change. Participants will have regular phone and in-person MD and nutritionist communication over the course of the 12-week study. All individuals will be asked to perform SMBG at least 4 times a day (before breakfast, lunch, dinner, and bedtime). The daily SMBG records will be sent to Dr. Sanchez Rangel weekly for review to guide adjustment of insulin regimens. Target blood glucose levels will be between 80-130 mg/dl before meals and between < 180 mg/dl at bedtime. Throughout the study, individuals will be contacted via telephone call, email or through additional clinic visits as deemed necessary for maintenance of glycemic control. All individuals will receive education regarding the detection and proper management of hypoglycemia.




Primary Outcome Measures :
  1. Intracerebral concentrations of glucose [ Time Frame: Baseline ]
    Intracerebral concentrations of glucose across multiple brain locations, including frontal and occipital, as measured by MRSI will be compared following hyperglycemic clamp in uncontrolled T2DM individuals with short duration of diabetes and long duration of diabetes

  2. Intracerebral concentrations of glucose between T2DM patients [ Time Frame: 12 Weeks ]
    Intracerebral concentrations of glucose will be compared between T2DM patients before and after 12 weeks of intensification of their diabetes management


Secondary Outcome Measures :
  1. Verbal Recognition Memory (VRM) [ Time Frame: Baseline ]
    Verbal Recognition Memory assesses verbal memory and new learning. It measures the ability to encode and subsequently retrieve verbal information, with recall tapping into fronto temporal networks and recognition assessing hippocampal areas. Administration time: 10 minutes

  2. Verbal Recognition Memory (VRM) [ Time Frame: 12 Week ]
    Verbal Recognition Memory assesses verbal memory and new learning. It measures the ability to encode and subsequently retrieve verbal information, with recall tapping into fronto temporal networks and recognition assessing hippocampal areas. Administration time: 10 minutes

  3. Paired Associates Learning (PAL) [ Time Frame: Baseline ]
    Paired Associates Learning assesses visual memory and new learning. Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. Administration time: 8 minutes

  4. Paired Associates Learning (PAL) [ Time Frame: 12 Week ]
    Paired Associates Learning assesses visual memory and new learning. Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. Administration time: 8 minutes

  5. Spatial Working Memory (SWM) [ Time Frame: Baseline ]
    Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has notable executive function demands and provides a measure of strategy as well as working memory errors. Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes which have already been found to contain a token) and strategy and latency. Administration time: 4 minutes

  6. Spatial Working Memory (SWM) [ Time Frame: 12 Week ]
    Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has notable executive function demands and provides a measure of strategy as well as working memory errors. Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes which have already been found to contain a token) and strategy and latency. Administration time: 4 minutes

  7. Reaction Time (RTI) [ Time Frame: Baseline ]
    Reaction Time provides assessments of motor and mental response speeds, as well as measures of movement time, reaction time, response accuracy and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. Administration time: 3 minutes

  8. Reaction Time (RTI) [ Time Frame: 12 Week ]
    Reaction Time provides assessments of motor and mental response speeds, as well as measures of movement time, reaction time, response accuracy and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. Administration time: 3 minutes

  9. Pattern Recognition Memory (PRM) [ Time Frame: Baseline ]
    Pattern Recognition Memory is a test of visual pattern recognition memory in a 2-choice forced discrimination paradigm.Outcome measures include the number and percentage of correct trials and latency (speed of participant's response). Administration time: 4 minutes

  10. Pattern Recognition Memory (PRM) [ Time Frame: 12 Week ]
    Pattern Recognition Memory is a test of visual pattern recognition memory in a 2-choice forced discrimination paradigm.Outcome measures include the number and percentage of correct trials and latency (speed of participant's response). Administration time: 4 minutes

  11. Delayed Matching to Sample (DMS) [ Time Frame: Baseline ]
    Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory, for non-verbalizable patterns. Outcome measures include latency (the participant's speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response. Administration time: 7 minutes

  12. Delayed Matching to Sample (DMS) [ Time Frame: 12 Week ]
    Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory, for non-verbalizable patterns. Outcome measures include latency (the participant's speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response. Administration time: 7 minutes

  13. Rapid Visual Information Processing (RVP) [ Time Frame: Baseline ]
    Rapid Visual Information Processing is a measure of sustained attention. Outcome measures cover latency (speed of response), probability of false alarms and sensitivity. Administration time: 7 minutes

  14. Rapid Visual Information Processing (RVP) [ Time Frame: 12 Week ]
    Rapid Visual Information Processing is a measure of sustained attention. Outcome measures cover latency (speed of response), probability of false alarms and sensitivity. Administration time: 7 minutes

  15. Multitasking Test (MTT) [ Time Frame: Baseline ]
    The Multitasking Test is a test of the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Outcome measures for the Multitasking Test include response latencies and error scores that reflect the participant's ability to manage multitasking and the interference of incongruent task-irrelevant information on task performance (i.e. a Stroop-like effect).Administration time: 8 minutes

  16. Multitasking Test (MTT) [ Time Frame: 12 Week ]
    The Multitasking Test is a test of the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Outcome measures for the Multitasking Test include response latencies and error scores that reflect the participant's ability to manage multitasking and the interference of incongruent task-irrelevant information on task performance (i.e. a Stroop-like effect).Administration time: 8 minutes



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetics with HbA1c > 7.5% with short duration of diabetes <5 years or
  • Type 2 Diabetics with HbA1c > 7.5% longer duration of diabetes >5 years

Exclusion Criteria:

  • Patients treated with incretin-based therapies
  • Creatinine > 1.5 mg/dL
  • Hgb < 10 mg/dL
  • ALT > 3 X ULN
  • Untreated thyroid disease
  • Uncontrolled hypertension
  • Known neurological disorders
  • Untreated psychiatric disorders
  • Malignancy
  • Bleeding disorders
  • Smoking
  • Current or recent steroid use in last 3 months
  • Illicit drug use
  • Women: pregnancy, actively seeking pregnancy, or breastfeeding
  • Inability to enter MRI/MRS (per standard MRI safety guidelines)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283617


Contacts
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Contact: Elizabeth Sanchez Rangel, MD 1 (203) 785-5455 elizabeth.sanchezrangel@yale.edu
Contact: Janice Hwang, MD 203-785-6222 janice.hwang@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Contact: Elizabeth Sanchez Rangel, MD    203-785-5455    elizabeth.sanchezrangel@yale.edu   
Sponsors and Collaborators
Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04283617    
Other Study ID Numbers: 2000027293
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
continuous glucose monitoring
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs