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Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)
NCT05776563 · Yale University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Reversibility of Brain Glucose Transport and Metabolism in T2DM
About this study
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 criteria
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).
Study design
Enrollment target: 24 participants
Allocation: na
Masking: none
Age groups: adult
Timeline
Starts: 2024-07-19
Estimated completion: 2027-05-31
Last updated: 2025-01-14
Interventions
Behavioral: Nutrition visitsOther: Intensification of diabetes regimenOther: Continuous glucose monitor (CGM)
Primary outcomes
- • Brain glucose concentration in the occipital cortex week 0 (week 0)
- • Brain glucose concentration in the occipital cortex week 12 (week 12)
Sponsor
Yale University · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactElizabeth Sanchez Rangel, MD · contact · elizabeth.sanchezrangel@yale.edu · 203-785-6430
InvestigatorElizabeth Sanchez Rangel, MD · principal_investigator, Yale University
All locations (1)
Yale New Haven Hospital (YNHH) Research Unit (HRU)Recruiting
New Haven, Connecticut, United States