Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus

This study aims to understand how high blood sugar levels affect the brain in people with Type 2 Diabetes (T2DM) and if these changes can be reversed with better blood sugar control. You would receive regular nutrition counseling and work with an endocrinologist to manage your diabetes. You would also use a continuous glucose monitor (CGM) to track your blood sugar. Researchers will measure brain glucose concentration at the beginning and end of the 12-week study to see if improvements occur. To join, you need to be 18-60 years old, have Type 2 Diabetes with an HbA1c (a measure of average blood sugar) greater than 7.5%, and a BMI (body mass index) of 18 or higher. The study plans to enroll 24 participants, and its current status is unclear.

Study design: This is an interventional study planning to enroll 24 participants. It will assess the effects of intensified diabetes management on brain glucose transport.
What's involved: You would have a screening visit, wear a continuous glucose monitor (CGM) for 14 weeks, and have nutrition visits and endocrinologist consultations every two weeks for 12 weeks.
Compensation: Not stated in the trial record.
Follow-up: Brain glucose concentration will be measured at week 0 and again at week 12.

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

Recruiting

NAAges 18–60InterventionalBasic science

Yale University

~24 participants

Updated 2025-01-14 on ClinicalTrials.gov

What's tested:Nutrition visitsIntensification of diabetes regimenContinuous glucose monitor (CGM)

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Brain glucose concentration in the occipital cortex week 0

Measured over week 0

+1 more outcome measured

Conditions

Diabetes Mellitus, Type 2

Where it's being run

1 sites across 1 states

Connecticut1

Study leadership

Elizabeth Sanchez Rangel, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Elizabeth Sanchez Rangel, MD

[email protected]

203-785-6430

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

Brain glucose concentration in the occipital cortex week 0week 0
Intracerebral concentrations of glucose across the occipital cortex , as measured by MRS will be compared following hyperglycemic clamp in T2DM individuals at baseline (week0).
Brain glucose concentration in the occipital cortex week 12week 12
Intracerebral concentrations of glucose across the occipital cortex will be compared between T2DM patients before and after 12 weeks of intensification of their diabetes management.

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