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Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnetic Resonance Spectroscopy Imaging (MRSI)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18-60 medical history for Type 2 diabetes HbA1c > 7.5%, BMI ≥18 kg/m2 Be willing to adhere to the intensification of their diabetes regimen Exclusion Criteria: Creatinine > 1.5 mg/dL Hgb < 10 mg/dL, hematocrit of 37 % for males participants and 33 % for female participants ALT >3 x ULN untreated thyroid disease, uncontrolled hypertension known neurological disorders untreated psychiatric disorders malignancy bleeding disorders current or recent steroid use in last 3 months illicit drug use for women: pregnancy, actively seeking pregnancy, or breastfeeding inability to enter MRI/MRS (as per standard MRI safety guidelines).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Brain Glucose Levels in Participants with Type 2 Diabetes

    Arm Description

    Intensification of diabetes management

    Outcomes

    Primary Outcome Measures

    Change in magnetic resonance spectroscopy (MRS) to assess brain glucose changes
    Brain glucose changes in the occipital lobe will be measured by 1H MRS following hyperglycemic clamp in T2DM individuals at week 0 and at week 12. An improvement in glucose control indicates an increase in brain glucose levels at week 12 compared to historical control.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 6, 2023
    Last Updated
    July 25, 2023
    Sponsor
    Yale University
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05776563
    Brief Title
    Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)
    Official Title
    Reversibility of Brain Glucose Transport and Metabolism in T2DM
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    May 31, 2027 (Anticipated)
    Study Completion Date
    May 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to learn about the effects of high blood glucose levels in the brain and assess if the changes seen in individuals with poorly control T2DM can be reversed with good glucose control. The main question[s] it aims to answer are: To determine, whether abnormalities in brain glucose transport seen in individuals with uncontrolled diabetes, can be improved with better glucose control. Assess which factors, (duration of diabetes mellitus (DM) and glycemic control) contribute to changes in glucose transport Participants will have: A screening visit placement of a continuous glucose monitor (CGM) 2 weeks before the first magnetic resonance spectroscopy (MRS) at week 0 Additional visits/phone calls for intensification of diabetes management and nutrition visits Second magnetic resonance spectroscopy (MRS) at week 12

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Brain Glucose Levels in Participants with Type 2 Diabetes
    Arm Type
    Other
    Arm Description
    Intensification of diabetes management
    Intervention Type
    Other
    Intervention Name(s)
    Magnetic Resonance Spectroscopy Imaging (MRSI)
    Intervention Description
    baseline 1HMRSI imaging study, then will undergo intensification of their diabetes management for a period of 12-week and at the end of the intervention they will undergo 1H MRSI scanning to measure intracerebral and plasma glucose levels at euglycemia and following 2 hours of hyperglycemia using the clamp technique (target glucose 220 mg/dl) in the occipital region
    Primary Outcome Measure Information:
    Title
    Change in magnetic resonance spectroscopy (MRS) to assess brain glucose changes
    Description
    Brain glucose changes in the occipital lobe will be measured by 1H MRS following hyperglycemic clamp in T2DM individuals at week 0 and at week 12. An improvement in glucose control indicates an increase in brain glucose levels at week 12 compared to historical control.
    Time Frame
    baseline and week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18-60 medical history for Type 2 diabetes HbA1c > 7.5%, BMI ≥18 kg/m2 Be willing to adhere to the intensification of their diabetes regimen Exclusion Criteria: Creatinine > 1.5 mg/dL Hgb < 10 mg/dL, hematocrit of 37 % for males participants and 33 % for female participants ALT >3 x ULN untreated thyroid disease, uncontrolled hypertension known neurological disorders untreated psychiatric disorders malignancy bleeding disorders current or recent steroid use in last 3 months illicit drug use for women: pregnancy, actively seeking pregnancy, or breastfeeding inability to enter MRI/MRS (as per standard MRI safety guidelines).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elizabeth Sanchez Rangel, MD
    Phone
    203-785-6430
    Email
    elizabeth.sanchezrangel@yale.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth Sanchez Rangel, MD
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)

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