Diabetes Mellitus, Type 2
Conditions
Brief 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
Interventions
BEHAVIORALNutrition 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
OTHERIntensification 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.
OTHERContinuous 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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain glucose concentration in the occipital cortex week 0 | 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). |
| Brain glucose concentration in the occipital cortex week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| CGM metrics | 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 |
Countries
United States
Contacts
Primary ContactElizabeth Sanchez Rangel, MD
Outcome results
None listed