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

Official title

Reversibility of Brain Glucose Transport and Metabolism in T2DM

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

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 outcome measures

• Brain glucose concentration in the occipital cortex week 0 [Time frame: week 0]
• Brain glucose concentration in the occipital cortex week 12 [Time frame: week 12]

Secondary outcome measures (1)

• CGM metrics [Time frame: weeks 12]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Yale New Haven Hospital (YNHH) Research Unit (HRU) — New Haven

Identifiers

NCT: NCT05776563 · 2000034676 · 1K23DK132517-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗