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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05776563
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Nutrition visits — BEHAVIORAL
    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
  • Intensification of diabetes regimen — OTHER
    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.
  • Continuous glucose monitor (CGM) — OTHER
    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.

Study Details

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

Key Dates

Start date
Jul 19, 2024
Status verified
Jan 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Aim 1
    Intervention before and after study with subjects with uncontrolled T2DM to measured brain glucose transport specifically in the occipital lobe during acute hyperglycemia

Primary Outcome Measure

Brain glucose concentration in the occipital cortex week 0 [ Time Frame: week 0 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven Hospital (YNHH) Research Unit (HRU)New HavenConnecticut06520-

Find similar trials in New Haven, CT

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Yale New Haven Hospital (YNHH) Research Unit (HRU)· New Haven, CT

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