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

Study Overview
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Brief Summary
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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

Official Title
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Reversibility of Brain Glucose Transport and Metabolism in T2DM

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Magnetic Resonance Spectroscopy Imaging (MRSI)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Brain Glucose Levels in Participants with Type 2 Diabetes<br>Intensification of diabetes management | Other: Magnetic Resonance Spectroscopy Imaging (MRSI)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and week 12 |