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

Summary

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

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Elizabeth Sanchez Rangel, MD · Yale University

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-19

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• United States

Study Locations