RecruitingNot ApplicableNCT05776563

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

Reversibility of Brain Glucose Transport and Metabolism in T2DM


Sponsor

Yale University

Enrollment

24 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether improving blood sugar control in people with poorly controlled type 2 diabetes reverses abnormal changes in how the brain transports and uses glucose. Researchers believe that high blood sugar over time may permanently alter how brain cells take up sugar, and they want to test whether this can be corrected with better diabetes management. **You may be eligible if...** - You are between 18 and 60 years old with type 2 diabetes - Your HbA1c is above 7.5% (indicating suboptimal blood sugar control) - Your BMI is at least 18 kg/m2 - You are willing to intensify your diabetes treatment regimen **You may NOT be eligible if...** - You have reduced kidney function (creatinine above 1.5 mg/dL) - You have anemia, untreated thyroid disease, or uncontrolled high blood pressure - You have known neurological disorders - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNutrition visits

Participants will receive exercise and dietary counseling from a nutritionist and registered dietician with extensive experience with diabetes and obesity every 2 weeks during the 12 wee

OTHERIntensification of diabetes regimen

Patient will meet every 2 weeks in person or have regular phone calls with an endocrinologist to review glucose control and intensification of the diabetes regimens. Will follow the general strategies outlined in the Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes.

OTHERContinuous glucose monitor (CGM)

Individuals with uncontrolled T2DM will be asked use a CGM during the 12 week intervention, to monitor glucose control. Target blood glucose levels will be between 80-130 mg/dl before meals and \< 180 mg/dl at bedtime. Individuals not at goal with glycemic targets will undergo intensification of their regimen. Throughout the study, individuals will be contacted via telephone, email or through additional clinic visits as deemed necessary for maintenance of glycemic control.


Locations(1)

Yale New Haven Hospital (YNHH) Research Unit (HRU)

New Haven, Connecticut, United States

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NCT05776563


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