Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: Magnetic Resonance Spectroscopy Imaging (MRSI)
- Registration Number
- NCT05776563
- Lead Sponsor
- Yale University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brain Glucose Levels in Participants with Type 2 Diabetes Magnetic Resonance Spectroscopy Imaging (MRSI) Intensification of diabetes management
- Primary Outcome Measures
Name Time Method Brain glucose concentration in the occipital cortex week 0 week 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 12 week 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.
- Secondary Outcome Measures
Name Time Method CGM metrics weeks 12 Glycemic variability, time above range, time in range and time below range will be assessed by using EasyGV between groups at baseline and after 12 weeks of intervention
Trial Locations
- Locations (1)
Yale New Haven Hospital (YNHH) Research Unit (HRU)
🇺🇸New Haven, Connecticut, United States