Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)
Recruiting · NCT05776563 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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).
Where it is running
1 location listed across 1 US state.
- Yale New Haven Hospital (YNHH) Research Unit (HRU) - New Haven, Connecticut, United States