Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 60
Updated:5/19/2018
Start Date:January 18, 2018
End Date:January 2020
Contact:Janice Hwang, MD
Email:Janice.hwang@yale.edu
Phone:203-785-6222

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose: an Intervention Study

To investigate whether longer-term improvement of glycemic control in poorly controlled
diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased
polyol pathway activity.

Polyol pathway activity will decrease in diabetic individuals who undergo intensification of
their insulin treatment regimens as reflected by lower baseline brain intracellular fructose
levels and higher intracellular glutathione levels. Furthermore, following longer-term
improved glycemic control, patients may also have down-regulation of the pathway as reflected
by decreased production of intracellular fructose in response to hyperglycemic clamp.

Inclusion Criteria:

- 15 Type 2 DM subjects with HbA1C > 7.5%

- 15 Type 1 DM subjects with HbA1C > 7.5%

- Age 18-60

- BMI ≥18 kg/m2

- Weight ≤ 285 pounds

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,

- 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
We found this trial at
1
site
Anylan Center
300 Cedar Street
New Haven, Connecticut 06519
Principal Investigator: Janice Hwang, MD
?
mi
from
New Haven, CT
Click here to add this to my saved trials