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

Reversibility of Brain Glucose Transport and Metabolism in T2DM

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether better blood sugar control can improve how sugar moves into the brain in people with poorly controlled type 2 diabetes. It is for adults ages 18–60. It also looks at whether time living with diabetes and blood sugar control affect these changes.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–60 years old.
  • Have type 2 diabetes.
  • Have an HbA1c above 7.5%. This test measures average blood sugar.
  • Have a BMI of at least 18. BMI is a measure based on height and weight.
  • Sign and date a form agreeing to join the study.
  • Be willing and able to follow all study steps and stay for the full study.
  • Be willing to step up your diabetes treatment.

Who can't join

  • Have kidney, red blood cell, or liver blood test results outside the study’s limits.
  • Have untreated thyroid disease or high blood pressure that is not controlled.
  • Have a known brain or nerve disorder, or an untreated mental health disorder.
  • Have cancer or a bleeding disorder.
  • Use steroids now or have used them in the past 3 months.
  • Use illegal drugs.
  • Be pregnant, trying to become pregnant, or breastfeeding.
  • Be unable to safely have MRI/MRS scans, which use strong magnets to study the brain.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (1)

CT