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

Yale University

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Nutrition visits; Other: Continuous glucose monitor (CGM); Other: Intensification of diabetes regimen

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05776563

1K23DK132517-01A1 (U.S. NIH Grant/Contract)

2000034676

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Aim 1

Other group

Description:

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

Treatment:

Other: Intensification of diabetes regimen

Other: Continuous glucose monitor (CGM)

Behavioral: Nutrition visits