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

Description

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

Diabetes Mellitus, Type 2

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Study Overview

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Study Details

Study overview

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

Reversibility of Brain Glucose Transport and Metabolism in T2DM

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

Condition
Diabetes Mellitus, Type 2
Intervention / Treatment

-

Contacts and Locations

New Haven

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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).

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Yale University,

Elizabeth Sanchez Rangel, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2027-05-31