Recruiting

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

ClinicalTrials.gov IDNCT05776563

PhaseNA

Enrollment24

SponsorYale University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Diabetes Mellitus, Type 2

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

Interventions

Behavioral: Nutrition 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
Other: Intensification 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.
Other: Continuous 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.

Primary outcomes

Brain glucose concentration in the occipital cortex week 0 (week 0)
Brain glucose concentration in the occipital cortex week 12 (week 12)

Eligibility information

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 locations

Yale New Haven Hospital (YNHH) Research Unit (HRU), New Haven, Connecticut 06520 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.