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NCT Number: NCT05776563

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

New Haven, Connecticut, 06520, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nutrition visits

Behavioral

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

Intensification of diabetes regimen

Other

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.

Continuous Glucose Monitor (CGM)

Other

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 outcomes

  1. Brain glucose concentration in the occipital cortex week 0

    Time frame: week 0

    Intracerebral concentrations of glucose across the occipital cortex , as measured by MRS will be compared following hyperglycemic clamp in T2DM individuals at baseline (week0).

  2. Brain glucose concentration in the occipital cortex week 12

    Time frame: week 12

    Intracerebral concentrations of glucose across the occipital cortex will be compared between T2DM patients before and after 12 weeks of intensification of their diabetes management.

Secondary outcomes

  1. CGM metrics

    Time frame: weeks 12

    Glycemic variability, time above range, time in range and time below range will be assessed by using EasyGV between groups at baseline and after 12 weeks of intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Sanchez Rangel, MD

CONTACT

[email protected]

203-785-6430

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Official study title

Reversibility of Brain Glucose Transport and Metabolism in T2DM

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2023
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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