Hyperglycemia
Conditions
Brief summary
Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess cerebrospinal fluid levels of metabolites.
Interventions
OTHERBrain MRS during hyperglycemic clamp
All patients will undergo brain MRS at baseline and following 2 and 4 hours of hyperglycemia using the clamp technique
OTHERAnalysis of Metabolites in cerebrospinal fluid
All patients will have the option to undergo a lumbar puncture for analysis of metabolites in cerebrospinal fluid
Sponsors
American Diabetes Association
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Type 2 DM with HbA1C treated with metformin, sulfonylurea, insulin, or combination OR age-matched, non-diabetic obese (BMI \> 30 kg/m\^2) OR age-matched lean, healthy control subjects (BMI \< 25 kg/m\^2) * Age 18-55 * BMI 18-45 kg/m\^2
Exclusion criteria
* Creatinine \> 1.5 mg/dL * Hgb \< 10 mg/dL * ALT \> 2.5 x ULN * Untreated thyroid disease * Uncontrolled Hypertension * Known Neurological Disorders * Untreated Psychiatric Disorders * Malignancy * Bleeding Disorders * Smoking * Current or recent steroid use in last 3 months * Illicit drug use * Pregnancy, actively seeking pregnancy, or breastfeeding * Inability to enter MRI/MRS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolite Measurements by MRS | 4 hours post hyperglycemia | metabolite levels will be measured by MRS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satiety Ratings | 4 hours post hyperglycemia | Satiety will be measured using a visual analog scale |
| Hunger Ratings | 4 hours post hyperglycemia | Hunger will be measured using a visual analog scale |
| Cognitive State | 4 hours post hyperglycemia | Participants will be asked to complete basic cognitive testing using the mini-mental status exam and the Montreal cognitive assessment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cerebrospinal fluid cell count | 2 weeks post MRS testing | Metabolite levels will be measure in collected spinal fluid |
| protein levels | 2 weeks post MRS testing | Metabolite levels will be measure in collected spinal fluid |
Countries
United States
Outcome results
None listed