Actively Recruiting
Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)
Led by Yale University · Updated on 2025-01-14
24
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
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
CONDITIONS
Official Title
Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willing to comply with all study procedures and available for the study duration
- Male or female aged 18-60 years
- Medical history of Type 2 diabetes
- HbA1c greater than 7.5%
- Body mass index (BMI) of 18 kg/m2 or higher
- Willing to adhere to intensification of diabetes treatment regimen
You will not qualify if you...
- Creatinine level greater than 1.5 mg/dL
- Hemoglobin less than 10 mg/dL or hematocrit below 37% for males and 33% for females
- Alanine aminotransferase (ALT) more than three times the upper limit of normal
- Untreated thyroid disease
- Uncontrolled high blood pressure
- Known neurological disorders
- Untreated psychiatric disorders
- Any malignancy
- Bleeding disorders
- Current or recent steroid use within the last 3 months
- Illicit drug use
- For women: pregnancy, actively seeking pregnancy, or breastfeeding
- Unable to safely undergo MRI/MRS according to standard safety guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yale New Haven Hospital (YNHH) Research Unit (HRU)
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
E
Elizabeth Sanchez Rangel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here